A product investigation was conducted.Visual inspection: it was noticed that the only blade interface sleeve was returned for investigation.The returned device was missing the sub-components such as extractor screw shaft, post and dowel pin.It is possible that the missing parts can affect the device's functionality.Hence, the complaint can be confirmed for the reported condition, further observation reveals that internal thread portion of the blade interface sleeve at the proximal side was found to be stripped/worn which can also impact the functionality of the device.Also, device has scratches which would not affect the device functionality.Conclusion: the exact cause for the missing components is unknown, but it was likely while the device was disassembled in sterile processing and the sub components may have been misplaced.For stripped conditions, its likely due to wear from repeated use over the 17+ years of lifespan.After a visual inspection, it is determined that the device is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.A device history record (dhr) review was conducted: part number: 357.378, synthes lot number: 4436462, supplier lot number: n/a, release to warehouse date: 27nov2002, expiration date: n/a, manufactured by synthes (b)(4).Review of the device history record showed that there are potential issues during the manufacture of the product that would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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