SMITH & NEPHEW, INC. TWINFIX ULTRA TI 5.5 W/3 UB; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number 72202897 |
Device Problem
Material Separation (1562)
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Patient Problem
No Information (3190)
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Event Date 10/19/2020 |
Event Type
malfunction
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Event Description
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It was reported that during a procedure when screwing the anchor, the twinfix broke from the stem, part of the handle, so the pins that holds it hooked off.The broken pieces were retrieved by suction and no additional bone holes were performed.The procedure was completed with a backup device and no delay or further complications 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 an isolated event.A review of risk management files found that the reported failure was:- pathological conditions of bone, such a cystic changes or severe osteopenia, which would compromise secure anchor fixation - incomplete anchor insertion may result in poor anchor performance - use of excessive force during insertion can cause failure of the suture anchor or insertion device.A two-finger ao technique should be used to insert the anchor.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.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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