It was reported that approximately four months after a shoulder procedure using a multifix s peek 5.5mm anchor, the anchor had backed out of the bone and was floating loose in the shoulder.This deficiency resulted in a revision surgery.The failed implant was removed with graspers, scar tissue was removed and the rotator cuff was successfully re-repaired using another implant.No additional complications have been reported as a result of this procedure.
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The subject multifix s implant was used for repair and returned for evaluation.Only the implant was returned.Relationship between the reported incident and returned device was not established.The multifix s inserter handle was not returned for evaluation.The anchor body and sleeve were returned for evaluation.Blue and cobraid magnumwire and a blue unidentified suture were found properly snared on the anchor.Per complaint description, the anchor pulled out from place post-surgery.The complaint was verified, but the root cause for the the anchor pulled out from place post-surgery could not be determined with confidence.Factors unrelated to the manufacturing or design of the device that could have contributed to the reported event includes: poor bone quality.Use of suture other than qualified #2 magnumwire, ultrabraid, and ultratape sutures.The instruction for use (ifu) outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.The ifu contraindicates the use of this device in poor bone quality as implant pull out may occur and the use of suture other than #2 magnumwire, ultrabraid, and ultratape sutures.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
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