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 Separation (1562)
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Patient Problem
No Information (3190)
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Event Date 07/29/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).
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Event Description
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It was reported that a suturefix anchor was used, after the 1.9mm drill, while inserting the anchor the white deployment button suddenly dropped out from the handle.Finally the doctor decided to use a 1.7mm suturefix instead.Another 3 anchors were used uneventfully.A a delay shorter than 30 minutes and no further 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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Event Description
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It was reported that a suturefix anchor was used, after the 1.9mm drill, while inserting the anchor the white deployment button suddenly dropped out from the handle.Finally the doctor decided to use a 1.7mm suturefix instead.Another 3 anchors were used uneventfully.A a delay shorter than 30 minutes and no further 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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B5: updated.H10 h3, h6: one 72203854 suturefix ultra suture anchor device used in treatment, was returned for evaluation.No anchor was returned.The inserter device; handle body, button, trigger cover were returned.Cobraids were returned without the textile anchor attached.They were torn and frayed at the anchor location.The trigger was found partially locked indicating an incomplete insertion.The anchor was not fully deployed.Once fully deployed, the white locking button cannot be removed.Pull back on the one time deployment trigger produced the audible click.The distal tip of the outer tube tip was unusually flared and creased.It indicated contact with another device or instrument.Inspection of the inner shaft confirmed that the fork tines were intact and undamaged.Following instructions for use recommended prep is essential for successful use.Instructions for use highlights several precautions that can affect successful fixation.Smith and nephew suturefix anchors are intended for the reattachment of soft tissue to bone.Per instructions for use: ¿it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Only use the recommended drill bits and drill guides intended for use with the suturefix ultra suture anchor.Use of other instruments may injure the patient, damage the instruments, or compromise fixation.Once seated do not rotate the suture anchor device in the bone as this may cause device failure.Incomplete anchor insertion may result in poor anchor performance.Pull back slowly on the handle to remove insertion device.The anchor will remain in the bone.¿ complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.No root cause related to the manufacture of this device was confirmed.Product met specifications upon release to distribution.
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