SMITH & NEPHEW, INC. BIOSURE PK 6 X 25MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number 72202260 |
Device Problem
Material Separation (1562)
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Patient Problem
No Information (3190)
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Event Date 09/07/2020 |
Event Type
malfunction
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Event Description
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It was reported that during an acl the biosure scattered into few smaller pieces a 1,5 cm of the screw stayed inside, it has to be retrieved piece by piece.A competitor devices was used in the same bone hole and all the pieces were removed.The procedure was completed without a significant delay.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future occurrence of the reported event.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of the instructions for use found certain site preparation techniques may contribute to breakage.A review of risk management files found that the reported failure was documented appropriately.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
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Search Alerts/Recalls
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