MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK RC DISPOSABLES KIT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	FIBERTAK RC DISPOSABLES KIT
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
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 02/12/2025, it was reported by a sales representative via (b)(4) that an ar-3650ds disposables kit for 2.6 fibertak anchors and (qty.3) of an ar-3632sp 2.6 fibertak sp soft anchor had an issue when repairing a supraspinatus tear.The first ar-3632sp 2.6 fibertak sp soft anchor was deployed successfully, but the drilling was problematic for the first anchor.The 2.6 drill was confirmed to be appropriately chucked.The second socket was more difficult, and some metal shavings were noticed around the drill site.The surgeon had to reverse the drill to remove it from the drill guide, which caught the sutures from the first anchor and pulled it from the socket.The surgeon asked for two more ar-3632sp 2.6 fibertak sp soft anchors and attempted to deploy them in each socket, but both pulled out.The surgeon abandoned the fibertaks and moved on to 5.5mm corkscrews, which were successfully deployed in the previously drilled sockets.All metal shavings were removed from the site, and the medial row sutures were passed, tied, and bridged to two 5.5mm swivelocks as planned.This was discovered during an arthroscopic rotator cuff repair procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 02/18/2025: there was no significant delay to the case and no additional anesthesia.There were no negative effects or significant damage due to immediately opening corkscrews and inserted them in the same sockets that were drilled for the fibertaks.
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 misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: FIBERTAK RC DISPOSABLES KIT
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 21467544
• Report Number: 1220246-2025-00664
• Device Sequence Number: 21020354
• Product Code: LXH
• UDI-Device Identifier: 00888867291799
• UDI-Public: (01)00888867291799(11)230828(17)280731(10)15134040
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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: FIBERTAK RC DISPOSABLES KIT
• Device Catalogue Number: AR-3650DS
• Device Lot Number: 15134040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2023
• 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