MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYS, BIOCOMP 2.9MM PUSHLOCK SHRT; NON-DEGRADABLE FIXATN FASTENER

Model Number	IMPLANT SYS, BIOCOMP 2.9MM PUSHLOCK SHRT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/06/2025, a sales representative reported via email that an ar-2923bcs biocomposite pushlock implant system anchor broke during insertion.No fragments were retained in the patient, and the procedure was completed using an ar-2923bc biocomposite pushlock suture anchor without further issues.This was discovered during a labral repair procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 10/10/2025: ar-2923bcs biocomposite pushlock implant system anchor broke into pieces during insertion.The bone quality was assessed as hard.There was no significant delay, no additional anesthesia was administered, and no adverse effects were noted.No photographs were taken to document the event.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b3, g3, h3, h6, 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 improper bone preparation.

• Brand Name: IMPLANT SYS, BIOCOMP 2.9MM PUSHLOCK SHRT
• 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: 23302601
• Report Number: 1220246-2025-04620
• Device Sequence Number: 9953062
• Product Code: MAI
• UDI-Device Identifier: 00888867335035
• UDI-Public: (01)00888867335035(11)240917(17)260831(10)15318575
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/03/2026

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 Expiration Date: 08/31/2026
• Device Model Number: IMPLANT SYS, BIOCOMP 2.9MM PUSHLOCK SHRT
• Device Catalogue Number: AR-2923BCS
• Device Lot Number: 15318575
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown