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.E3: reporter is a j&j employee.H3, h4, h6: part number: 03.019.017, lot number: 74p0435, manufacturing site: haegendorf, release to warehouse date: 26 october 2020.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the weld between hook and scala, broke, resulting in the hook detaching.No other product problem identified.A dimensional inspection was not performed as it is not applicable to the complaint condition.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the depth gauge for multiloc hum nling sys, p/n: 03.019.017, lot: 74p0435 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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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It was reported that on (b)(6) 2023, an ans depth gauge fell apart when attempting to measure for a screw length.When going to measure for the locking screw through the aiming arm, the probe just fell off, and the surgeon had to grab out the hook part that was in the bone.After the depth gauge broke, the pieces were put aside and the surgeon measured of the drill, and opened another set for the distal locking.The case was finished without any delays or other problems.This report involves one depth gauge for multiloc humeral nailing system.This is report 1 of 1 for (b)(4).
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