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Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/14/2022 |
Event Type
malfunction
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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.Additional narrative: this report is for an unknown plates: trauma/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Postal (b)(6).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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Device report from synthes reports an event in japan as follows: it was reported that on july 14, 2022, the patient underwent the orif surgery with the va-tcp and the locking screw for fracture of distal radius.During surgery, when the surgeon inserted the locking screw to the plate hole in the second distal row, torque could not be applied to the locking screw and the locking screw went through the plate hole.Since the surgeon was drilling using a guiding block, and the va mechanism was not applied, it is unlikely that the screw thread breakage occurred.The locking screw was extracted without any problem and another locking screw was not used for the plate hole.The surgery was completed successfully within 30 minutes delay.The surgeon commented that he thinks there is no danger of perforating the bone head.Patient is in stable condition.No further information is available.This report is for one (1) unk - plates: trauma.This is report 2 of 2 for complaint (b)(4).
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Search Alerts/Recalls
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