MAUDE Adverse Event Report: ARTHREX, INC. DBL LOADED 5.5MM BC SWVLK; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	DBL LOADED 5.5MM BC SWVLK
Health Effect - Clinical Codes	Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/07/2021
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
It was reported during a rotator cuff repair procedure, after inserting the ar-2323bct-2 swivelock.Additional information 6/15/2021.It was reported during a rotator cuff repair procedure, the surgeon started to insert the ar-2323bct-2 swivelock medially.Halfway through insertion, the surgeon decided he needed to take it out and recheck the angle.As he was pulling the still intact anchor out, the eyelet tore away from the driver and eyelet sutures and was left in the bone.Additional information 6/17/2021.It was reported during a rotator cuff repair procedure, the surgeon started to insert the ar-2323bct-2 swivelock medially.Halfway through insertion, the surgeon decided he needed to take it out and recheck the angle.As the surgeon removed the device the ar0-2323bct-2 broke.The remaining parts of the anchor and driver were removed when he pulled it out and the broken eyelet remains in the patient.

• Brand Name: DBL LOADED 5.5MM BC SWVLK
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12124240
• Report Number: 1220246-2021-03364
• Device Sequence Number: 1493540
• Product Code: MAI
• UDI-Device Identifier: 00888867251069
• UDI-Public: 00888867251069
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• 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): 07/06/2021

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: 01/31/2023
• Device Model Number: DBL LOADED 5.5MM BC SWVLK
• Device Catalogue Number: AR-2323BCT-2
• Device Lot Number: 12791814
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1