MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, PEEK, MINI HIP SUTURETAK; NON-DEGRADABLE FIXATN FASTENER

Model Number	SUTURE ANCHOR, PEEK, MINI HIP SUTURETAK
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a hip arthroscopy the firewire sutures frayed almost immediately on the surface when manipulating the device with the birdbeak, they could then no longer be shuttled/used.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: SUTURE ANCHOR, PEEK, MINI HIP SUTURETAK
• 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: 23807653
• Report Number: 1220246-2025-05616
• Device Sequence Number: 12684281
• Product Code: MBI
• UDI-Device Identifier: 00888867227613
• UDI-Public: (01)00888867227613(11)220825(17)270731(10)14995636
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/15/2025

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: SUTURE ANCHOR, PEEK, MINI HIP SUTURETAK
• Device Catalogue Number: AR-1934PHS-20
• Device Lot Number: 14995636
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2022
• 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