Catalog Number 159025SND |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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A physician reported the 1.0mm k-wires get stuck repeatedly in the canula of the 2 in 1 drill.No patient injury was reported.Surgical delay was notified by the surgeon as three minutes which he finds substantial on a surgery of 20 minutes.
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Manufacturer Narrative
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Given the description of the event and the observations during documentation review, the root cause cannot be determined as the issue is not confirmed.No anomaly was found during the review of the design specifications, manufacturing and inspections specifications and quality records.No trend is observed.Associated risk will be updated according to the risk review results.In addition, the inspection of the returned product does not reveal any anomaly and do not confirm the issue.
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Event Description
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N/a.
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Manufacturer Narrative
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This is a correction follow-up report to update codes.
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Event Description
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N/a.
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Search Alerts/Recalls
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