SMITH & NEPHEW, INC. SUTUREFIX ULTRA AHR S W/2 UB STR 1 BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number 72203854 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/06/2020 |
Event Type
malfunction
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Event Description
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It was reported that when the sururefix was being used, the anchor did not hold and it frayed.The damaged device was extracted and the problem was solved using a back up device.No delay or further complication was 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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One 72203854 suturefix ultra anchor suture anchor used for treatment, was not returned for evaluation.Due to product unavailability evaluation was limited.If further information becomes available the complaint can be revisited.Factors that may affect device performance include: device ability, surgical ability, implant location and tissue condition.Influences unrelated to manufacture that could compromise product performance or integrity include: 1) inadvertent rotation of device during anchor seating.2) use of other than recommended smith and nephew drill and proper size and spade style drill bit ensuring proper depth.3) unexpected bone density/condition.4) the primary cutting edges of the drill were not sharp, had dings or burrs.5) product stressed from loss of axial alignment.Ifu contains several precautions that can affect successful fixation.It is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition or product/procedure failure that supported the allegation.Product met specifications upon release to distribution.Allegation rate of occurrences continue to be monitored via surveillance.No further investigation is warranted at this time.Relationship between the event and device was not confirmed.
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