Product complaint # (b)(4).Reporter is a j&j sales representative.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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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It was reported that on (b)(6) 2021, during testing of a set at loaners department, the retractor body items component parts broke off in pieces.There was no patient involvement.This complaint involves one (1) device.This report is for (1) retractor body.This report is 1 of 1 (b)(4).
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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.H3, h6: part: 03.816.001, lot: 9450467, manufacturing site: hägendorf, release to warehouse date: 03.Aug.2015.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the retractor body (p/n: 03.816.001, lot number: 9450467) was received at us customer quality (cq).Visual inspection of the complaint device showed the two screw angulation blades had broken.Device failure/defect identified? yes.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the two screw angulation blades had broken.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 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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