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The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 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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Product complaint #(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: h3, h6: investigation summary investigation flow: adverse event.Visual inspection: the 5.0 ti lckng screw t25 sd 38 f/im nail-s (p/n: 04.005.528s, lot number: 96p8946 ) was received at cq west chester for investigation.Visual inspection of the complaint device showed no damage or defects with the complaint device.Device failure/defect was not identified.Investigation conclusion: the complaint is not confirmed as no issues were identified on the complaint device that would contribute to the adverse event.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot manufacturing location: monument.Manufacturing date: 06-apr-2021.Expiration date: 28-feb-2031.Part number: 04.005.528s, 5.0mm ti locking screw w/t25 stardrive 38mm f/im nail-sterile.Lot number: 96p8946 (sterile).Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria apart.Inspection sheet, inspect whirl threads, vibe, flute / final inspection ns053611 rev l, met all inspection acceptance criteria.Packaging label log (pll) lppf rev e, lmd rev a was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 19726 supplied by (b)(4) 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(s) reviewed: part number: 04.005.528.999, 5.0mm ti screw blank 36mm 05.0 nail lock screw w/sd25.Lot number: 83p9778.Lot quantity: (b)(4).One hundred-twenty pieces were scrapped in cell at op #10, warm head blank.One hundred-ten pieces due to taper depth being too deep and ten pieces due to a machine warm-up issue.Production order traveler met all inspection acceptance criteria apart from the one hundred-twenty pieces noted.Part number: 23020, tialnbci4.98.Lot number: 11l9988.Lot quantity: (b)(4) lbs.Inspection instruction met all inspection acceptance criteria.Certified test report supplied by (b)(4) dated 08-jul-2019 was reviewed and determined to be conforming.Lot summary report dated 09-sep-2019 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.Device history review 04-oct-2021: dhr reviewed.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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