Model Number MD455 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/27/2021 |
Event Type
Injury
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Event Description
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It was reported to aesculap inc.That a lewin bone clamp serr 180mm (part # md455) was used during a procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the working end of the instrument broke.The fragment was retrieved from the patient, and then the procedure was continued and successfully completed without issue.The complaint device was returned to the manufacturer for evaluation.An additional medical intervention was necessary.Although requested, additional information has not been made available.The adverse event is filed under aic reference (b)(4).
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
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Manufacturer Narrative
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Investigation results: visual investigation: one working end is broken off.The broken off fragment is not available for investigation.Investigation was carried out visually and microscopically.The fracture surface shows an area with corrosion, this could be an indication of an incipient crack preceding the fracture.The "aesculap" inscription of the instrument is made by etch marking.Etch marking has not been used at aesculap for over 20 years, indicating the approximate age of the instrument.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity 1 (10) x probability of occurrence 2(10) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.
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Event Description
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No changes required.
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Search Alerts/Recalls
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