|
Model Number TIGHTROPE ABS, 14 MM BUTTON |
Device Problem
Break (1069)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 07/29/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
It was reported that a patient had undergone an acl reconstruction (b)(6) 2020.At a post op visit the ar-1588tb-1, tightrope abs 14mm button (lot 10727270), was observed to be broken in half.The patient underwent a second surgery (b)(6) 2020 at the same facility, by the same surgeon.During the second surgery the acl button was removed and an interference screw was utilized to fixate the acl allograft.It was reported that the patient did not suffer any known or reported trauma post the original procedure.
|
|
Manufacturer Narrative
|
Complaint confirmed.One unpackaged ar-1588tb-1 was received for investigation.Visual inspection identified that the returned ar-1588tb-1 had split down the centerline.No fragments from the breakage site were returned for investigation.Material analysis concluded that the ar-1588tb-1 button met all as-received specifications.It was noted that the button broke post op, resulting in the revision.As such, potential causes for the reported event include insufficient fixation of the device, and/or non-compliance.
|
|
Search Alerts/Recalls
|
|
|