MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH PEEK S-TAK KNOTLESS HIP USE; NON-DEGRADABLE FIXATN FASTENER

Model Number	SUTR ANCH PEEK S-TAK KNOTLESS HIP USE
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an instability repair surgery issues with the device occurred.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or do a second surgery.20-feb-2023 update dw further information were provided that the implants mentioned in the appendix did not work.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.  arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint can only be confirmed with a picture or the complaint device.One unpackaged ar-1938phs serial/batch number (b)(6) was received for investigation.The only received part for this complaint was the suture.Visual evaluation found that the suture was frayed.No problem was found related to the complaint.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces upon insertion.

• Brand Name: SUTR ANCH PEEK S-TAK KNOTLESS HIP USE
• 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: 19484139
• Report Number: 1220246-2024-05217
• Device Sequence Number: 8030336
• Product Code: MBI
• UDI-Device Identifier: 00888867097216
• UDI-Public: 00888867097216
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K120155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/07/2024

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: 06/30/2026
• Device Model Number: SUTR ANCH PEEK S-TAK KNOTLESS HIP USE
• Device Catalogue Number: AR-1938PHS
• Device Lot Number: 13681679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• 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