Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is synthes employee.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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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.The device has been 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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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.A device history record (dhr) review was conducted: part # 319.006 , synthes lot # 4751758 , supplier lot # na , release to warehouse date: 30mar2004 , manufactured by synthes brandywine.Tthe material was reviewed and the hardness value was confirmed to meet the specification with no (relevant) non-conformance noted.No non-conformance reports (ncr's) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.A product investigation was conducted.Device condition: visual inspection performed at customer quality observed broken needle on the returned depth gauge.The needle of the depth gauge is broken off at the interface to the slider body.All remaining components of the depth gauge showed minimal signs of wear.This is consistent with the reported complaint condition.The device condition agree with the complaint description and the complaint was confirmed.The cause for this complaint condition cannot be definitely determined to be use error, misuse/abuse, non-compliance, or postoperative trauma.Dimensional analysis and document/specification review: relevant drawings for the returned device (both current revision and from the time of manufacture) were reviewed, and no design issues were noted.Dimensional inspection: needle shaft specification: ø 1.25 +0/- 0.05 mm, needle measured dimensions: shaft ø: 1.25 mm; conforming while no definitive root cause could be determined, it is possible that any unintended excessive forces such as device being dropped during usage/handling could have contributed to complaint condition.The material used during production was reviewed, and the hardness value was confirmed to meet the specification with no (relevant) non-conformance noted.Conclusion: the overall complaint condition was confirmed; however, no product design issues or manufacturing discrepancies were identified during this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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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