SYNTHES GMBH GUIDE BLOCK F/2.4MM VA-LCP VOLAR RIM DSTL RAD PL/7H HD/LT; PLATE, FIXATION, BONE
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Catalog Number 03.115.801 |
Device Problem
Material Deformation (2976)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/27/2023 |
Event Type
malfunction
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Event Description
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Device report from japan reports an event as follows: it was reported that on (b)(6) 2023, the patient underwent an orif surgery for a distal radius fracture.Before surgery, it was found that the guiding block attachment screw had been extremely bent.Because it was so greatly deformed, it was impossible to remove the screw and replace it with a screw of a different size, making it unusable.A guiding block was borrowed from a nearby facility, it was prepared in time for the surgery.The surgery was completed successfully with no surgical delay.No further information is available.This report is for a guide block f/2.4mm va-lcp volar rim dstl rad pl/7h hd/lt.This is report 1 of 1 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.D2: additional procode: hwc d9: 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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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.H4, h6 part: 03.115.801, lot: l069512, release to warehouse date: 27 sep 2016, manufacturing site: werk hägendorf , expiration date: 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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