MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH PEEK S-TAK KNOTLESS 3X12.7MM; NON-DEGRADABLE FIXATN FASTENER

Model Number	SUTR ANCH PEEK S-TAK KNOTLESS 3X12.7MM
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on (b)(6) 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint is not confirmed.Upon evaluation, the anchor was not returned for investigation.The driver returned has no issues.Functional testing was not performed due to the missing components of the device.No problem found for returned parts.The most likely cause for the reported failure can be attributed to user-applied excessive mechanical forces.
Event or Problem Description
It was reported that during a bankart and slap repair surgery when driving the anchor in, it was damaged and no stability was obtained.The bone was properly prepared.There was no harm for patient, operator or third party.The surgery was finished successfully with a different device, ar-2325bss-1.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: SUTR ANCH PEEK S-TAK KNOTLESS 3X12.7MM
• 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: jared engle ; 8009337001
• MDR Report Key: 19180389
• Report Number: 1220246-2024-02367
• Device Sequence Number: 7412345
• Product Code: MAI
• UDI-Device Identifier: 00888867282421
• UDI-Public: 00888867282421
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K140855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2024

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 Model Number: SUTR ANCH PEEK S-TAK KNOTLESS 3X12.7MM
• Device Catalogue Number: AR-1938PS-1
• Device Lot Number: 14997609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• 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