MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCHBIO-COMP S-TAK KNOTLESS; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	SUTR ANCHBIO-COMP S-TAK KNOTLESS
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
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.
Event or Problem Description
It was reported during the shuttling process of the ar-1938bc sutures as the surgeon started to tug on the shuttling stitch, the suture tore and ripped out.This same exact issue occurred with a total of four ar-1938bc (lot: 11515574).Two of the anchor bodies were retained in the joint and two were removed intact.The case was completed by opening a new box and using an additional four ar-1938bc.No unplanned incisions were necessary.

• Brand Name: SUTR ANCHBIO-COMP S-TAK KNOTLESS
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11655751
• Report Number: 1220246-2021-02900
• Device Sequence Number: 11819888
• Product Code: MAI
• UDI-Device Identifier: 00888867097186
• UDI-Public: 00888867097186
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K180594
• 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): 04/13/2021

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: SUTR ANCHBIO-COMP S-TAK KNOTLESS
• Device Catalogue Number: AR-1938BC
• Device Lot Number: 11515574
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 04/13/2021
• Patient Sequence Number: 1