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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.D2b.Additional pro-code: hwc.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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 h3/h4/h6: device history lot: manufacturing location: monument.Manufacturing date: 30-apr-2022.Expiration date: unknown.Part number: 04.233.442s, rfn/14mm/420mm 5 degree bend/pe inlay/sterile.Lot number: 696p614 (sterile).Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria apart from the one piece noted.Inspection sheet, in-process / inspect dimensional / final rev d met all inspection acceptance criteria.Inspection sheet, rfn assembly inspection, rev b met all inspection acceptance criteria.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.(b)(6) provided by (b)(4)was found to be conforming.There was no pll included in this dhr.Therefore, the pll for this lot could not be reviewed and the expiration date could not be notated.This lot met all dimensional and visual 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 ¿adverse event received for dvt¿ 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 batch: device history review: 29-apr-2024: dhr reviewed: this lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Component parts were not reviewed as the reported complaint condition of ¿¿adverse event received for dvt" does not indicate breakage of the or any of its components.Therefore, review of the raw materials would not be pertinent to the reported 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.
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