Model Number N/A |
Device Problems
Difficult to Insert (1316); Difficult To Position (1467)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/25/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.
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Event Description
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It was reported that the endcap couldn't be inserted into the nail.The surgeon used and finished the surgery with an alternative one with no patient injury reported.
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Manufacturer Narrative
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This report is being submitted to reflect additional information not available at the time of the initial submission.Current information remains insufficient to determine the cause of the event.(b)(4).
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.The end cap was received for evaluation.It was found that there is sufficient damage to the leading thread which likely was the cause of the device not being able to be inserted into the nail, thus the complaint is confirmed.The dimensions of the threads was not conducted as there was damage to the threads.The device history records were reviewed and no deviations or anomalies were identified.A definitive root cause of the reported issue cannot be determined with the information provided.
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Search Alerts/Recalls
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