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: manufacturing location: monument, manufacturing date: oct 11, 2019, expiration date: sept 1, 2029, part number: 04.037.213s, 12mm/125 deg ti cann tfna 200mm - sterile, lot number: 18p3428 (sterile).Production order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final ns071302 rev e met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection ns067861 rev b met all inspection acceptance criteria.Packaging label log (pll) lmd rev ad was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn (b)(4) supplied by ethicon (abq) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿surgery successfully completed with a more than 30-minute delay¿ does not indicate breakage of the nail or any of its components.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.Device history review this lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture 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.
|
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) 12mm/125 deg ti cann tfna 200mm - sterile.This is report 4 of 4 for (b)(4).
|