SMITH & NEPHEW, INC. BONE ANCHORS WITH ARTHROSCOPIC DELIVERY; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Catalog Number 4403 |
Device Problem
Break (1069)
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Patient Problem
No Information (3190)
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Event Date 08/14/2020 |
Event Type
Injury
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Event Description
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It was reported that during a rotator cuff repair with regeneten, three bone anchors seemed to not line up with the punch, causing the implants to broke during insertion.All pieces were removed from the patient with a grasper.The procedure was successfully completed without significant delay using a back-up device in a different spot.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 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 a repeat issue.A review of the instructions for use found excessive force applied during anchor deployment may result in damage to the tissue, to the material being fixated, or to the anchor.A review of risk management files found that the reported failure was documented appropriately.Clinical evaluation found that no further medical assessment is warranted at this time.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 reoccurrence of the reported event.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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