MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWVLK SP, 4.75X24.5MM; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	BIO-COMP SWVLK SP, 4.75X24.5MM
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/04/2021
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 after the ar-2324bcm anchor was implanted, the surgeon passed the suture through the tendon and was tying a knot and the suture broke with very little tension.The anchor was removed, but the metal tip of the anchor is still in the patient.No injuries occurred and the surgery was completed successfully with a 6.5 corkscrew.

• Brand Name: BIO-COMP SWVLK SP, 4.75X24.5MM
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11872402
• Report Number: 1220246-2021-03161
• Device Sequence Number: 4269469
• Product Code: MAI
• UDI-Device Identifier: 00888867026865
• UDI-Public: 00888867026865
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K191226
• 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): 05/24/2021

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 Model Number: BIO-COMP SWVLK SP, 4.75X24.5MM
• Device Catalogue Number: AR-2324BCM
• Device Lot Number: 12541568
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 05/24/2021
• Patient Sequence Number: 1