SYNTHES GMBH K-WIRE ATTACHMENT FOR PEN DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 05.001.037 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/28/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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.: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.(b)(4).
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Event Description
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It was reported from (b)(6) that during post surgery sterilization, it was observed that the kirschner (k) wire attachment device was leaking.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Manufacturer Narrative
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This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.H10 additional narrative: this device was returned for evaluation; however, during pre-repair assessment, it was determined that the device passed all operational specifications and no failure was identified.Therefore, the reported condition was not confirmed and an assignable root cause was not determined.
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Search Alerts/Recalls
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