SYNTHES GMBH DHS/DCS-SCR Ø12.5 L115 SST; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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Catalog Number 280.150S |
Device Problems
Device-Device Incompatibility (2919); Material Deformation (2976)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/31/2024 |
Event Type
malfunction
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Event Description
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Device report from synthes reports an event in united kingdom as follows: it was reported on january 31, 2024, that dhs screw would not fit onto plate.It felt firm on assembly, but i couldn't insert a plate over it.I had to remove the screw from a bone, checked with a plate- no go.This was discovered during the procedure.There was surgical delay of 5 minutes.There was patient involvement.This report is for one (1) dhs/dcs-scr ø12.5 l115 sst this is report 1 of 1 for complaint (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 not expected to be returned for manufacturer review/investigation.H3, h6: 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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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.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part: 280.150s lot: 9852871 manufacturing site: werk balsthal release to warehouse date: 14 march 2016 product was not returned.Based on the information available, it has been determined that no corrective and 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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.
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