Follow-up #1 and final report submitted to update sections d.3, g.1, g.4, g.7, h.2, h.3, h.6, h.10 and h.11 based on the results of investigation.It was reported that the issue was that the reamer and the mics attachment stripped the metal on the back of the straight reamer.Case type: tha surgical delay: =15 minutes product evaluation and results: as per the image provided in the communication, it shows that the metal on the back of the straight reamer is stripped.Further inspection not performed as no items were returned.Product history review: review of the device history records indicate 98 devices were manufactured and accepted into final stock on 02-16-2017 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 207084, lot 06021216 shows 1 additional complaint related to the failure in this investigation.The complaint is pr: (b)(4).Conclusions: the failure is confirmed from the image provided in the communication log.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
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