Udi: (b)(4).Investigation summary: according to the information provided, it was reported that the drill bits of the latarjet system, difficult to pass over the bone.Which made the surgery difficult.The device was received and evaluated.Visual observations reveals that the device has some marks of wear and use as usual on these type of reusable devices.The device does not show any structural anomalies on the shaft.On magnification at the drill bit, it was observed that the edges are dull.A manufacturing record evaluation was performed for the finished device 16e01 number, and no non-conformance's were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint can be confirmed.The possible root cause can be attributed to the constant and rough use.Since this is a reusable device, the constant manipulation between surgeries, the repeated drilling and sterilization process can lead in drill bit degradation, however, this cannot be conclusively determined.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.
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