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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: e3: reporter is a j&j employee.H3, h4, h6: part number: 319.003; lot number: 77p7101; manufacturing site: haegendorf; release to warehouse date: 8th january 2021.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.The photo investigation revealed that the sleeve of the 319.003, depth gauge f/scr ø1.3 - 1.5 meas-range is missing.The overall complaint was confirmed as the observed condition of the 319.003, depth gauge f/scr ø1.3 - 1.5 meas-range would contribute to the complained device issue.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection confirmed the reported allegation, the sleeve component is missing.Additionally, the distal needle is bent.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the [depth gauge f/scr ø1.3 - 1.5 meas-range] would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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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