We have recently collaborated with a specialist medical supplier and manufacturing company, focusing on the development and innovation of surgical implant systems and orthopaedic technology.
A stainless steel, surgical drill bit suffered premature fracturing, so we were asked to investigate the nature and cause of the failure to help prevent the likelihood of a similar failure occurring again in the future.
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We carried out a comprehensive investigation on the surgical drill bit to find the cause of failure. Our tests include visual inspection, Fractography/ Microscopical investigations, SEM analysis to reveal any material defects and damage. We also carried out Hardness Testing in accordance with BS EN ISO 6507-1 2005 to observe the materials’ ability to resist deformation.
The visual inspection of the drill bit revealed surface staining and damaged edges. During the SEM/EDAX analysis, Calcium deposits (bone) were found on the fractured drill bit although it had been thoroughly sterilised after use.
Our findings indicated the drill bit failure was due to tensile overload, and the wear of the fracture surface and damage to the drill edges suggested adverse operational conditions.
All the customers’ products are developed, designed, and tested to meet internationally required quality standards, so our analysis meant that the customer was able to re-assess their manufacturing processes and implement improvements to product design.
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Product testing for surgical instruments is critical to evaluate their safety, efficiency and functionality in real-life medical procedures. Testing helps us to understand the performance and durability of the component under different conditions. The goal of testing is to ensure that the instruments meet regulatory standards and can be safely and effectively used by healthcare professionals.
Testing surgical instruments for safety is crucial to ensure patient safety and successful surgical outcomes. Potential risks such as infection, tissue damage, and other adverse events can be minimized or prevented through rigorous testing. This helps to ensure that surgical instruments perform their intended functions safely and effectively. Testing can also help to identify any defects or malfunctions in the instruments before they are used on patients. Overall, testing is an essential step in the development and maintenance of safe and reliable surgical instruments.
If surgical instruments fail during surgery, it could potentially lead to complications such as extended surgery time, increased risk of infection or injury, and may require additional surgeries or medical interventions. It is important for surgical teams to have contingency plans in place to address any issues that may arise during a procedure.
Have you experienced a recent product or sample failure? To find out more about our detailed failure investigation services, contact us on 0121 514 0602 or complete an online consultation form.
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You can speak to us now on +44 (0)121 514 0602
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You can speak to us now on +44 (0)121 514 0602