SYNTHES GMBH 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 7H HD/3H SHAFT/RIGHT; PLATE, FIXATION, BONE
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Catalog Number 02.111.730 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/26/2023 |
Event Type
malfunction
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Event Description
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It was reported that in (b)(6) 2023, the surgeon was putting in a va buttress screw into the most radial proximal portion of the distal screws for plate 02.111.730 and the threads from the screw would not lock into the plate.The screw was exchanged for another va buttress screw and the threads of the second screw would not lock into the plate either.The guide block and drill guide for guide block were used properly.All other screws locked into the plate.The procedure was successfully completed with 15 minutes of surgical delay.No fragments were generated.This report is for a 2.4mm va-lcp 2-clmn vlr dstl radius pl 7h hd/3h shaft/right.This is report 1 of 3 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 not expected to be returned for manufacturer review/investigation.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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Event Description
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No other medical intervention was required.
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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.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.D10: concomitant device updated from unk screw to 1.8 va lckng buttress pin t8 sd rec/20.
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Search Alerts/Recalls
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