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Catalog Number 214.030 |
Device Problem
Unintended Movement (3026)
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Patient Problem
Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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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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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that a patient underwent a surgical procedure on an unknown date, more than a year ago.The patient experienced persistent pain, and x-ray images taken showed screw failure.Concomitant device reported: unknown plate, (part # unknown, lot # unknown, quantity unknown).This is report 2 of 10 for (b)(4).This complaint has been updated with the 10 of 13 devices.Please see the linked complaint (b)(4) for the additional two devices.
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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.Concomitant medical products: complainant part is not expected to be returned for manufacturer review/investigation.Device history: a dhr review was not performed for this pi.Part/lot combination was not available.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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Updated event description: it was reported the screws securing a plate appeared deformed.The revision occurred on (b)(6) 2019 and was completed successfully.All hardware was removed.No surgical delay.Patient was listed as stable.It is unknown what the patient was revised to.Concomitant device reported: lcp plate (part # (b)(4), lot # unknown, quantity unknown).
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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.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 history lot part: 214.030, lot: l140403, manufacturing site: grenchen, release to warehouse date: 09.14.2016.A manufacturing record evaluation was performed for the finished device lot number, 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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