MAUDE Adverse Event Report: ARTHREX, INC. DBL LOADED 4.75MM BIO-COMP SWVLK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	DBL LOADED 4.75MM BIO-COMP SWVLK
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a subscap repair, after both dbl loaded anchors were placed, the surgeon then passed the first suture and noticed that the middle of the suture was frayed.Once the surgeon pulling on the suture fully, the ar-2324bcc-2 tore.The surgeon then moved to the second anchor and noticed fraying a little higher on the suture.The surgeon was able to cut and remove the damaged section without further issue.No patient harm reported.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation identified that the sutures had frayed.

• Brand Name: DBL LOADED 4.75MM BIO-COMP SWVLK
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12267458
• Report Number: 1220246-2021-03468
• Device Sequence Number: 4447459
• Product Code: MAI
• UDI-Device Identifier: 00888867097995
• UDI-Public: 00888867097995
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 09/01/2021

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: 02/28/2025
• Device Model Number: DBL LOADED 4.75MM BIO-COMP SWVLK
• Device Catalogue Number: AR-2324BCC-2
• Device Lot Number: 12874414
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1