ARTHREX, INC. BIO-COMP SWVLK C,CLD 4.75X19.1MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
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Model Number BIO-COMP SWVLK C,CLD 4.75X19.1MM |
Device Problem
Flaked (1246)
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Patient Problem
Insufficient Information (4580)
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Event Date 07/30/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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It was reported that during an elbow surgery the green plastic of the device chipped of inside the patient.No fragments remained inside the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
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Manufacturer Narrative
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Complaint confirmed.One unpackaged ar-2324bcc-1 (no batch identifier present) was received for investigation.Visual inspection identified that the distal tip of the c8795 driver outer sleeve had ballooned out, with a crack visible along the diameter.The biocomposite screw and peek eyelet were present along the driver shaft.The proximal threads of the biocomposite screw were damaged, and the distal-most threads had been stripped.The peek eyelet appeared to remain undamaged.The cause of the event remains undetermined.It was noted that the method used to prepare the bone, as well as the bone quality encountered during the procedure, were not recorded.As such, a probable cause can be attributed to improper bone preparation.
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