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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint regarding anchor breakage is confirmed based on field images showing fractured component fragments.After reviewing all available information; including the returned device (if applicable), photographs, videos, event description, and any additional field input.Arthrex has determined the most probable cause.The likely cause is a user error, attributed either to misaligned insertion or prying/leveraging of the screw during placement.The allegation concerning missing traction tower components cannot be confirmed, as no supporting photographic evidence was provided.
Event or Problem Description
On (b)(6) 2025, an arthrex subsidiary employee reported via email that an anchor breakage occurred during the repair procedure involving ar-1923bc biocomposite pushlock suture anchors (2.9 x 15.5 mm).Upon arrival at the facility, it was noted that items were missing in the surgical kit, specifically components required for the traction tower.Once the issue was resolved and the surgery commenced, the reporting technician assisted with instrumenting the procedure.The perforations were performed by a medical resident, while the surgeon inserted the anchors.The first anchor broke due to incorrect alignment during insertion.A second anchor was placed correctly and remained intact.Despite confirming the material was appropriate for use, subsequent anchors continued to break during insertion.The broken pieces were retrieved from the patient, and the case was completed with another product.This was discovered during a left shoulder arthroscopy for bankart and hill-sachs lesions, along with a bankart instability repair procedure on (b)(6) 2025.Additional information has been requested on 10/28/2025.

• 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: 23547069
• Report Number: 1220246-2025-05064
• Device Sequence Number: 9683320
• Product Code: MAI
• UDI-Device Identifier: 00888867023017
• UDI-Public: (01)00888867023017(11)240507(17)280430(10)15244600
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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
• Report Date (Section B): 11/13/2025

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: BIO-COMP-SITE P-LCK 2.9X15.5MM
• Device Catalogue Number: AR-1923BC
• Device Lot Number: 15244600
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown