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	11/28/2025
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 11/28/2025, a sales representative reported that during a cuffmend procedure, an ar-1926bcsp biocomposite pushlock anchor experienced an issue.After pre-punching the pilot hole, the surgeon encountered moderate resistance while inserting the anchor, not excessive.Using proper technique, the anchor was malleted along a trajectory similar to the punch, but the anchor body sheared vertically in half.The surgeon successfully removed all fragments and completed the case using another ar-1926bcsp biocomposite pushlock anchor in a different pilot hole.The case was delayed by approximately two minutes, and no patient harm was reported.Additional information was received on 12/04/2025: this occurred on (b)(6) 2025 for a rotator cuff repair procedure.The bone was assessed as normal, and it is uncertain if additional anesthesia was administered.No photos were taken of the event.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is a user error, including improper bone preparation and/or improper surgical technique associated with the device.Direction for use dfu-0362-eo revision 4 self-punching, pushlock and swivelock, suture anchors.G.Precautions: 3.Pushlock only: insert the driver until the anchor body makes contact with the bone.Preview and adjust suture tension, if necessary.Tension will not increase during final advancement of the anchor body.4.Swivelock only: during anchor insertion, ensure that the angle of the anchor insertion is coaxial to that of the previously prepared bone socket.5.Pushlock only: ensure that the anchor body is in full contact with the bone before advancing the anchor body.The complaint allegation was not confirmed.No evidence of that failure was received.

• 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: 23837335
• Report Number: 1220246-2025-05677
• Device Sequence Number: 20081837
• Product Code: MAI
• UDI-Device Identifier: 00888867395213
• UDI-Public: (01)00888867395213(11)250224(17)290131(10)15394147
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/03/2026

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 Model Number: 3.5MM PUSHLOCK, BIOCOMP, SELF-PUNCHING
• Device Catalogue Number: AR-1926BCSP
• Device Lot Number: 15394147
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2025
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2025
• 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