Device is an instrument and is not implanted or explanted.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.A review of the device history records has been requested and is currently pending completion.Device 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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Product investigation summary: one compression/distraction instrument (part 03.111.021 / lot t974968) was received.Upon visual inspection of the complaint device, it can be seen that the tooth wheel assembly is missing from the device, which resulted in the complaint condition.A root cause could not be determined, but it is most likely the wheel assembly was disassembled from the instrument for cleaning and got misplaced during sterile processing.The complaint condition is confirmed.The compression/distraction instrument is part of synthes orthopaedic foot instrument system, which utilized for reconstructive orthopaedic surgery.The instrument allows for compression/distraction of joints or bones.The relevant drawing was reviewed.The design history was found to not impact the complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.Device history record review: manufacturing location: (b)(4)- manufacturing date: april 30, 2012.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.The original event description states that the discovered issue resulted in the ¿rending of the device unable to tighten.¿ this statement should read: ¿rendering the device unable to tighten.¿ device 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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