MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE ABS, 14 MM BUTTON; PIN, FIXATION, SMOOTH

Model Number	TIGHTROPE ABS, 14 MM BUTTON
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/29/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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.

• Brand Name: TIGHTROPE ABS, 14 MM BUTTON
• Common Device Name: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10414283
• Report Number: 1220246-2020-02036
• Device Sequence Number: 2682798
• Product Code: HTY
• UDI-Device Identifier: 00888867019638
• UDI-Public: 00888867019638
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110123
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: TIGHTROPE ABS, 14 MM BUTTON
• Device Catalogue Number: AR-1588TB-1
• Device Lot Number: 10727270
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other