MAUDE Adverse Event Report: ARTHREX, INC. 3.5MM PUSHLOCK, BIOCOMP, SELF-PUNCHING; BIO SOFT TISSUE FIXATN FASTNR

Model Number	3.5MM PUSHLOCK, BIOCOMP, SELF-PUNCHING
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 2/5/2024, it was reported by a sales representative via email that an ar-1926bcsp biocomposite pushlock anchor and an ar-19032c fiberstitch rc had an issue.In this case, they first needed to fixate the patch medially with ar-19032c fibersitch rc.The surgeon deployed the first anchor of the ar-19032c fibersitch rc, but when the surgeon used the wheel to deploy the second anchor, the wheel would not budge.They cut this one out and used two more ar-19032c fiberstitch rcs, which worked as intended.To fixate the patch laterally, the surgeon used the ar-1926bcsp 3.5 self-punching biocomposit push lock.The surgeon could self-punch the first bit of the inserter in with ease.However, when he went to mallet the anchor, it abnormally shattered.The bone quality was normal, and the angle at which the anchor was being inserted was the same angle at which it was punched.Two additional ar-1926bcsp push locks were implanted as intended to complete the repair.No extra time was added to the case, and no harm was done to the patient.This was discovered during a cuffmend procedure on (b)(6) 2024.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex concluded that the most likely cause of the reported failure is user error, including improper bone preparation, misaligned insertion, and/or prying or levering the device during insertion, which resulted in the device damage.The complaint allegation was confirmed based on the customer's attached picture, which displays the device with the tip broken off.

• Brand Name: 3.5MM PUSHLOCK, BIOCOMP, SELF-PUNCHING
• 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: 18776489
• Report Number: 1220246-2024-01111
• Device Sequence Number: 8531935
• Product Code: MAI
• UDI-Device Identifier: 00888867395213
• UDI-Public: 00888867395213
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K221099
• 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): 06/05/2025

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: 3.5MM PUSHLOCK, BIOCOMP, SELF-PUNCHING
• Device Catalogue Number: AR-1926BCSP
• Device Lot Number: 15183136
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2023
• 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