MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,PEEK P-LCK,2.9X 12.5MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTR ANCH,PEEK P-LCK,2.9X 12.5MM
Medical Device Problem Codes	Positioning Failure (1158); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
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 24 april 2025, it was reported by a sales representative via email that 2 x ar-3638h-1 knotless hip fibertak and one ar-2923ps, sutr anchpeek p-lck2.9x 12.5mm were reported to have failed during use.This occurred on (b)(6) 2025, during a right hip arthroscopy & labral repair.It was reported surgeon performing a labral repair of right hip.Surgeon using knotless hip fibertak suture anchors.2x anchors deployed already into joint.Staff opened a 3rd anchor.Unfortunately, the sutures had unravelled from the inserter and were unable to be re-positioned onto the inserter.A 4th anchor was then opened and used, and unfortunately pulled straight back out.All pieces of the suture anchor removed from the joint.Surgeon then opted to use a hip pushlock anchor with 1.3mm suture tape.Upon insertion, it was noted that the eyelet broke.Likely due to suboptimal trajectory on insertion.The anchor was removed with no pieces remaining in joint.The case was completed successfully using a stryker cinclock.There was case involvement.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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 the most likely cause.The method of bone preparation was not specified.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: SUTR ANCH,PEEK P-LCK,2.9X 12.5MM
• 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: 22044027
• Report Number: 1220246-2025-02090
• Device Sequence Number: 12986498
• Product Code: MAI
• UDI-Device Identifier: 00888867028036
• UDI-Public: (01)00888867028036(11)240826(17)290731(10)15307351
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K101679
• 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,Followup
• Report Date (Section B): 08/27/2025

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,PEEK P-LCK,2.9X 12.5MM
• Device Catalogue Number: AR-2923PS
• Device Lot Number: 15307351
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown