MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH HIP BIO-COMP P-LCK 2.9X12.5MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTR ANCH HIP BIO-COMP P-LCK 2.9X12.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
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
On 07/01/2025, a sales representative reported via email that (qty.3) of an ar-2923bch suture anchor biocomposite hip pushlock eyelets consecutively broke off during implantation.The issue occurred despite the use of proper surgical technique.The threads on the affected anchors were damaged, preventing reassembly.The case was completed, and no reported pieces broke off inside the patient.This was discovered during a hip labral repair procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested on 07/10/2025.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional field information, arthrex was able to determine the most likely cause.The most likely cause of the reported failure is user error, including improper bone preparation and/or the angle of insertion is not coaxial with the previously prepared bone socket.These factors may have contributed to the malfunction or compromised the integrity of the implant during the procedure.

• Brand Name: SUTR ANCH HIP BIO-COMP P-LCK 2.9X12.5MM
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 22569532
• Report Number: 1220246-2025-03019
• Device Sequence Number: 3993982
• Product Code: MAI
• UDI-Device Identifier: 00888867195844
• UDI-Public: (01)00888867195844(11)250317(17)270228(10)15405217
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K101679
• 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): 11/05/2025

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: SUTR ANCH HIP BIO-COMP P-LCK 2.9X12.5MM
• Device Catalogue Number: AR-2923BCH
• Device Lot Number: 15405217
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/01/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown