MAUDE Adverse Event Report: ARTHREX, INC. BIOCOMPOSITE PUSHLOCK SP 4.5MM X 28MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIOCOMPOSITE PUSHLOCK SP 4.5MM X 28MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/02/2024
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 (b)(6) 2024, it was reported by a sales representative via phone that an ar-1922bcm suture anchors pilot snapped off.This occurred during a rotator cuff repair on (b)(6) 2024, the pilot snapped off and couldn't be threaded back on.All fragments were retrieved.The case was completed using another ar-1922bcm.No additional anesthesia was administered.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 08/04/2024 additional information was received from a sales representative via email who stated there was not an instrument used to prepare the bone socket.Used a self-punching anchor on the greater tuberosity.The patients bone quality was average.
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 a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: BIOCOMPOSITE PUSHLOCK SP 4.5MM X 28MM
• 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: 19991830
• Report Number: 1220246-2024-07176
• Device Sequence Number: 8461490
• Product Code: MAI
• UDI-Device Identifier: 00888867022898
• UDI-Public: 00888867022898
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K082810
• 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,Followup
• Report Date (Section B): 06/11/2025

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: BIOCOMPOSITE PUSHLOCK SP 4.5MM X 28MM
• Device Catalogue Number: AR-1922BCM
• Device Lot Number: 15150476
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2024
• Supplement Date Received by Manufacturer: 08/04/2024; 06/05/2025
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 12/20/2024; 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown