SYNTHES GMBH MULTIFUNCTION ROD F/INSERTION INSTR; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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Catalog Number 03.168.010 |
Device Problem
Entrapment of Device (1212)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 07/05/2022 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).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.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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Event Description
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Device report from synthes reports an event in india as follows: it was reported that on (b)(6) 2022, the compression device was broken during compression and tip of broken device is engaged with blade.Surgery was delayed for 10 minutes due to the reported event.The reported procedure was successfully completed.This report is for one (1)
(b)(4).This is report 1 of 1 for complaint multifunction rod f/insertion instr.
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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.Investigation summary =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 tip of the multifunction rod f/insertion instr has broken, the broken fragment was not returned.The device, component or fragment remains in patient issues could be not confirmed since x-ray evidence was not provided.No others problems were found.A dimensional inspection was not performed for the multifunction rod f/insertion instr due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to excessive/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 multifunction rod f/insertion instr 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 history review = product code: 03.168.010, lot #: 36p3183: a manufacturing record evaluation was performed for the finished device 03.168.010 lot # 36p3183, and no non-conformance was identified.
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