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	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10-dec-2025, a sales representative reported via phone that an ar-19032c fiberstitch rc implant 1.5 experienced deployment issues during a shoulder rotator cuff repair and cuffmend procedure.The first anchor was difficult to deploy, and after deploying the second anchor, a broken suture was observed upon removal of the inserter.Both sutures and anchors were removed from the patient using a shaver and kingfisher instrument.A second ar-19032c fiberstitch rc implant 1.5 was opened and functioned as intended.Subsequently, an ar-1926bcsp biocomposite pushlock anchor was inserted, and tension was applied to the suture.During anchor deployment, the anchor split longitudinally.All fragments were retrieved using a shaver and kingfisher instruments.The incident resulted in a 15-minute case delay with no additional anesthesia administered and no reported patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided, which may include the returned device (if available), photographs, videos, event description, and any additional field input, arthrex has determined the most likely cause.The most likely cause is attributed to user-related factors such as off-axis loading, improper bone preparation, or prying and leveraging the device with excessive force.

• 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: 23933873
• Report Number: 1220246-2025-05914
• Device Sequence Number: 13164596
• Product Code: MAI
• UDI-Device Identifier: 00888867395213
• UDI-Public: (01)00888867395213(11)240808(17)280731(10)15299709
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/13/2026

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: 15299709
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2024
• 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