Catalog Number 519110ND |
Device Problem
Crack (1135)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/22/2018 |
Event Type
malfunction
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Manufacturer Narrative
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To date the device involved in the reported incident has not been received for evaluation.
The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
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Event Description
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It was reported by a company representative on behalf of the physician that on (b)(6) 2018 a 519110nd device for nail fixation was cracked around the base of the metal post that holds the nail in place.
There was a 10 minute delay in surgery.
No impact to the patient was noted and the doctor was able to complete the procedure.
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Manufacturer Narrative
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Investigation completed on 09mar2018.
The product not returned therefore investigation for root cause cannot be performed.
However, review and comparison of surgical technique show improper gesture that might cause degradation of the support device near the reception axis (this assembly was not provided for being impacted).
In conclusion, complaint is not verified.
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Manufacturer Narrative
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The device was returned to the manufacturer for physical evaluation.
Failure analysis confirmed the incident but could not determine the root cause.
However, review and comparison of surgical technique show improper gesture that might cause degradation of the support device near the reception axis (this assembly was not provided for being impacted).
Review of dhr does not show any anomaly.
Complaint is verified.
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Search Alerts/Recalls
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