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	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/01/2025, a sales representative reported a complaint via email regarding an ar-1926bcsp biocomposite pushlock anchor.No additional details were provided at the time of the report.Additional information was received on 08/12/2025: during a rotator cuff repair with augmentation (cuffmend) on 07/31/2025, the eyelet of the ar-1926bcsp biocomposite pushlock anchor was not properly secured to the implant and was subsequently removed and retrieved.The case was completed using a replacement ar-1926bcsp biocomposite pushlock anchor.The procedure was delayed by a few minutes to obtain a new implant, but no additional anesthesia was administered.No adverse effects were reported.
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.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 method of bone preparation was not specified.The most likely cause for the reported failure can be attributed to a manufacturing issue; however, due to the device not being returned, we are unable to confirm the reported event.

• 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: 22850496
• Report Number: 1220246-2025-03550
• Device Sequence Number: 12867270
• Product Code: MAI
• UDI-Device Identifier: 00888867395213
• UDI-Public: (01)00888867395213(11)240507(17)280430(10)15244853
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/20/2025

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: 15244853
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/01/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown