Model Number 4.5 BIOCOMPOSITE FT WITH TIGERTAIL |
Device Problem
Defective Device (2588)
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Patient Problems
Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/21/2023 |
Event Type
malfunction
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Event Description
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It was reported that, during a rotator cuff surgery, issues with two anchors occurred.During the insertion of the first anchor, the corksrew frayed during the tenodesis.The second anchor could not be fixated and the surgeon was able to pull the anchor out without cutting the sutures as the sutures were stuck inside.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or do a second surgery.
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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16-oct-2023 update dw.Further information were provided that the initially provided part number ar-1927bcft-45-1 was incorrect.The issue was related to an ar-1927bcf-45-1 and that the suture of the first anchor frayed and everything was retrieved out of the patient.The second anchor could be fixated however the suture on the top of the corkscrew became stuck and the surgeon had to cut it through to finish the surgery successfully.
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Manufacturer Narrative
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Additional info: b5, h6 updated correction: h1 to n/a.Arthrex previously submitted this event as a reportable malfunction out of an abundance of caution.Upon receiving additional information from the field that clarified the event and evaluation of the returned devices, it has been determined that this event does not meet the criteria of a reportable event under 21 cfr 803.
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Search Alerts/Recalls
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