Catalog Number 352.040 |
Device Problems
Device-Device Incompatibility (2919); Material Deformation (2976); Material Twisted/Bent (2981); Illegible Information (4050)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that on (b)(6) 2023, while inspecting the instruments after going through the decontamination process, it was noticed that several instruments were damaged.The handle with quick coupling, small was worn.The plastic on the handle was cracked.The drive adaptor qc for 5.0 schanz screws is a quick connect for shanz pins.Where the quick connect goes into the drill, it is worn and unable to go into the drill.The 5.0mm flexible shaft was worn.The tip of the reamer shaft has prongs on it, and the prongs were bent and unable to hold the reamer head in place.Another 5.0mm flexible shaft was damaged.The 5.0mm flexible shaft 620mm was worn.It was a long rear shaft, and the tip of the reamers shaft has prongs on it, and the prongs were bent and unable to hold the reamer head in place.It is unknown when the damage occurred to these items.There was no patient involvement.This report involves one 5.0mm flexible shaft.This is report 4 of 4 for (b)(4).
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Manufacturer Narrative
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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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j employee.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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.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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Manufacturer Narrative
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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, h4, h6: 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 synream flexshaft was deformed from the tip.This condition can attribute to the unable to assemble condition.No other defect was found.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.The etching information over the surface of the device was read without problems.Additionally, the device presents a worn appearance, consistent with normal and repetitive use over a long period of time consistent as an end of life indicator for the device.A dimensional inspection was not performed for the synream flexshaft as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the synream flexshaft 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.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Device history review (dhr): part # 352.040 lot # 4l36213 manufacturing site: werk bettlach release to warehouse date : 16 july 2019 expiration date: n/a supplier: n/a.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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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Search Alerts/Recalls
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