Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot part: (b)(4).Lot: (b)(4).Manufacturing site: (b)(4).Release to warehouse date: nov 25, 2019.Expiry date: nov 1, 2029.A manufacturing record evaluation was performed for the finished device part: 04.038.000s, lot: 23p5607, and no non-conformances were identified.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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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent osteosynthesis surgery for femoral trochanteric fractures by using the tfna implants.The surgery was successfully completed with a more-than-30-minute delay, but it was not reported how many minutes it was delayed.It was confirmed on (b)(6) that femoral supracondylar fractures had occurred, and reoperation was done by using plate and cable on (b)(6) 2020.There is no further information available.This report is for one (1) ti end cap for tfna 0mm extn - sterile.This is report 3 of 4 for (b)(4).
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