Additional device product code: hrs.(b)(4).A product investigation was performed.This complaint is confirmed.Surgeon reported that the "plate/screw failed".One plate was received at customer quality (cq) in 2 pieces.The break is transverse and located in the middle third of the plate in the center of the elliptical hole used for guide wires.The 6 returned screws show wear associated with implantation and explantation but are all intact.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned plate is already broken.No new malfunctions were identified.A visual inspection under 5x magnification, dimensional inspection, device history record (dhr) review and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.Relevant drawing was reviewed during this investigation.Based on visual inspection under 5x magnification, measurements at cq with calipernd with reference to product drawing 02_211_008, the 6 returned unknown screws were able to be definitively determined as the following.Qty (1) of 02.211.014, unknown lot#; qty (3) of 02.211.018, unknown lot#; qty (1) of 02.211.022, unknown lot#; qty (1) of 02.211.024, unknown lot#.Unable to determine a root cause based on the complaint details.No new, unique or different patient harms were identified as a result of this evaluation.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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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