MAUDE Adverse Event Report: ARTHREX, INC. BC SWIVELOCK, 3.9X17.9MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BC SWIVELOCK, 3.9X17.9MM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, it was reported by a sales representative via e-mail that (2) ar-2326bcc swivelocks failed.This occurred on (b)(6) 2021 during a large rcr.Standard technique and instrumentation was followed for insertion of the swivelock for lateral row fixation.The suture was loaded into the anchor and the eyelet was partially inserted by hand into the prepared socket.The surgeon tapped the swivelock with a mallet to drive it down into the bone and the tip snapped off.All fragments of this broken device were retrieved, and a new anchor was loaded and inserted in standard fashion.This time the swivelock anchor body would not advance into the bone.The surgeon removed all parts of the implant and proceeded to use a 4.75m swivelock to complete the case.There was no patient effect reported.
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.

• Brand Name: BC SWIVELOCK, 3.9X17.9MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 13087968
• Report Number: 1220246-2021-04210
• Device Sequence Number: 14723784
• Product Code: MAI
• UDI-Device Identifier: 00888867311282
• UDI-Public: 00888867311282
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K203495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/27/2021

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: 12/31/2022
• Device Model Number: BC SWIVELOCK, 3.9X17.9MM
• Device Catalogue Number: AR-2326BCC
• Device Lot Number: 12485603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 12/27/2021
• Date Device Manufactured: 01/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown