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

Model Number	SUTR ANCHBIO-COMP S-TAK KNOTLESS
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
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
On (b)(6) 2021 it was reported by a sales representative that an ar-1938bc knotless suture tak broke during an scr shoulder procedure.The suture broke and pulled free from the anchor during tensioning.The implant stayed in the patient but the broken sutures were removed.The surgeon drilled two additional holes and implanted two more anchors from a different lot and case was completed with no further issues.

• Brand Name: SUTR ANCHBIO-COMP S-TAK KNOTLESS
• 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: 13053596
• Report Number: 1220246-2021-04117
• Device Sequence Number: 20129880
• Product Code: MAI
• UDI-Device Identifier: 00888867097186
• UDI-Public: 00888867097186
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/21/2021

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: SUTR ANCHBIO-COMP S-TAK KNOTLESS
• Device Catalogue Number: AR-1938BC
• Device Lot Number: 12485448
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 12/21/2021
• 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