MAUDE Adverse Event Report: ARTHREX, INC. PEEK, SWIVELOCK TT, 4.75X19.1MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	PEEK, SWIVELOCK TT, 4.75X19.1MM
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/29/2025, a sales representative reported via email that an ar-2324 pctt peek swivelock suture malfunctioned during a rotator cuff repair procedure utilizing a speed bridge technique.The patient's bone quality was assessed as good, so the surgical team opted to use the silver punch.After 5 to 6 turns of the driver, the anchor did not appear to be advancing.The surgeon removed the anchor to repunch.At that point, the scrub technician attempted to twist the paddle so it would sit flush with the knob, but was unable to advance or retract the paddle.It simply spun and produced a clicking sound.A second ar-2324 pctt was opened and implanted without issue.This was discovered during use on (b)(6) 2025, with no patient harm reported.Additional information has been requested on 09/08/2025.Additional information received on 9/10/2025: the procedure was delayed about five minutes as the surgeon was trying to reverse the paddle and salvage the anchor.No additional anesthesia was needed.The case was completed using another ar-2324pctt peek swivelock suture form a different lot number.
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 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 a manufacturing issue; however, due to the device not being returned, we are unable to confirm the reported event.

• Brand Name: PEEK, SWIVELOCK TT, 4.75X19.1MM
• 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: 23099531
• Report Number: 1220246-2025-03969
• Device Sequence Number: 8618108
• Product Code: MAI
• UDI-Device Identifier: 00888867098121
• UDI-Public: (01)00888867098121(11)240617(17)290531(10)15274496
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• 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): 12/08/2025

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: PEEK, SWIVELOCK TT, 4.75X19.1MM
• Device Catalogue Number: AR-2324PCTT
• Device Lot Number: 15274496
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown