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

Model Number	SUTR ANCHBIO-COMP S-TAK KNOTLESS
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via phone that qty.3 of an ar-3636 fibertak rc suture anchor and an ar-1938bc suture anchor had an issue during an anterior labral repair revision surgery to remove non-arthrex products on 11/14/2023.When the first two ar-3636 fibertak rc suture anchors were inserted, it was noticed that the shuttle suture was frayed before shuttling.The sutures were cut and removed, and both anchors were removed in one piece; no piece of the anchors broke inside the patient.Another ar-3636 fibertak rc suture anchor was opened, but the inserter was bent straight out of the package and, therefore, could not be used in the procedure.An ar-1938bc suture anchor was also used, and the shuttling suture was frayed after being inserted into the patient.Those sutures were cut and removed, and the ar-1938bc suture anchor was removed in one piece from the patient; no piece of the anchor broke.All four complaint devices were discarded, and no case pictures were taken.Five new ar-3636 fibertak rc suture anchors (two with lot number 15109221 and three with lot number 15129639) and one ar-1926bc suture anchor, biocomposite pushlock (with lot number 14977547) were used to complete the procedure successfully with no impact to the patient.There was a case delay of under 15 minutes, and no additional anesthesia was needed.This occurred during use with no patient harm.
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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user-applied excessive force during the tightening process.

• Brand Name: SUTR ANCHBIO-COMP S-TAK KNOTLESS
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: emily shafer ; 8009337001
• MDR Report Key: 18291984
• Report Number: 1220246-2023-09292
• Device Sequence Number: 6696575
• 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,Followup
• Report Date (Section B): 10/28/2024

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: 04/30/2025
• Device Model Number: SUTR ANCHBIO-COMP S-TAK KNOTLESS
• Device Catalogue Number: AR-1938BC
• Device Lot Number: 15089864
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown