MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP-SITE P-LCK 2.9X15.5MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP-SITE P-LCK 2.9X15.5MM
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/13/2025
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 10/08/2025, an arthrex subsidiary employee reported via email that an ar-1923bc biocomposite pushlock screw fractured into multiple pieces, leaving it cracked on all sides.During the procedure, two ar-1923bc biocomposite pushlock anchors were successfully placed.When attempting to place a third anchor, which was from a different lot than the previous two, the same standard placement technique was used.The surgeon positioned the purple guide, the punch was removed, and the guide was impacted to secure it in place.Drilling was performed to the stop using a 2.9 mm drill bit.The labral tape ends were threaded, and the guide was removed to allow insertion of the anchor.Upon initial impact to insert the anchor, it fractured into several pieces.Although the anchor was impacted to the intended depth, it failed structurally and was removed.The case was completed using a peek anchor as a replacement.It was noted that the surgeon maintained firm control of the handle throughout the placement to ensure proper alignment.This event occurred during a procedure on (b)(6) 2025.
Additional Manufacturer Narrative
Complaint allegation is confirmed by the attached picture, which shows that the screw was broken off.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.Per dfu-0087-eo - e.Warnings - 6.Bioabsorbable only: attempting implantation into hard, dense bone and/or drilling/punching smaller diameter holes than recommended may cause failure (breakage) of the implant during insertion.G.Precautions - 3.Make sure to use the recommended drill bit or punch to create the bone socket.The quality of the bone encountered was not specified.The most likely cause of 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: BIO-COMP-SITE P-LCK 2.9X15.5MM
• 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: 23312626
• Report Number: 1220246-2025-04651
• Device Sequence Number: 4838443
• Product Code: MAI
• UDI-Device Identifier: 00888867023017
• UDI-Public: (01)00888867023017(11)230517(17)270430(10)15094040
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K173240
• 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): 02/02/2026

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: BIO-COMP-SITE P-LCK 2.9X15.5MM
• Device Catalogue Number: AR-1923BC
• Device Lot Number: 15094040
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/13/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown