MAUDE Adverse Event Report: ARTHREX, INC. 4.75MM BC KNOTLESS SWIVELOCK W/ TAPE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	4.75MM BC KNOTLESS SWIVELOCK W/ TAPE
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/03/2021
Type of Reportable Event	Malfunction
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 09/08/2021, it was reported by a sales representative via phone that an ar-2324kbcctt lot: 132416087 knotless swivelock, with tape shredded.This was discovered during use in a rotator cuff repair on (b)(6) 2021. the surgeon inserted the anchor, as he was trying to retrieve the shuttle suture, the suture frayed.The surgeon removed the entire ar-2324kbcctt, (anchor and sutures).This portion of the procedure was completed using ar-2324kbct.The surgeon used a second ar-2325kbctt lot:132416087, as he was running the repair stitch though the anchor, the sutures cut in half.The anchor was secure and left inside the patient and the sutures were cut and removed.The case was completed without further issues.

• Brand Name: 4.75MM BC KNOTLESS SWIVELOCK W/ TAPE
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12540113
• Report Number: 1220246-2021-03701
• Device Sequence Number: 11659108
• Product Code: MAI
• UDI-Device Identifier: 10888867351131
• UDI-Public: 10888867351131
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K193503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: 4.75MM BC KNOTLESS SWIVELOCK W/ TAPE
• Device Catalogue Number: AR-2324KBCCTT
• Device Lot Number: 13241607
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 09/28/2021
• Patient Sequence Number: 1