MAUDE Adverse Event Report: ARTHREX, INC.; NON-DEGRADABLE FIXATN FASTENER

Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/08/2024
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
On 10/14/2024, it was reported by a sales representative via email that the implant got stuck in an ar-3638dhc disposable kit for knotless hip fibertak.The anchor got stuck and could not come out.A new anchor was used to complete the case.This was discovered during a procedure on (b)(6) 2024.
Additional Manufacturer Narrative
Additional information: b5, g3.
Event or Problem Description
Additional information received on 10/25/2024: the sales representative has reported that the ar-3636h self bunching 1.8 knotless hip fibertak inserter got stuck in the ar-3638dhc disposable kit.The case was completed using a new ar-3638dhc disposable kit and the ar-3636h self bunching 1.8 knotless hip fibertak was able to be implanted.
Additional Manufacturer Narrative
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 error of the device due to applying excessive mechanical forces upon insertion.

• Brand Name: UNK
• 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: 20576757
• Report Number: 1220246-2024-08347
• Device Sequence Number: 12888781
• Product Code: MBI
• UDI-Device Identifier: 00888867295544
• UDI-Public: (01)00888867295544(11)240429(17)290331(10)15240702
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K203268
• 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,Followup
• Report Date (Section B): 07/08/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: 10/25/2024; 06/11/2025
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 11/18/2024; 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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