MAUDE Adverse Event Report: ARTHREX, INC. FBRTK SPDBRG IMP SYS W/ BC SWVLK; NON-DEGRADABLE FIXATN FASTENER

Model Number	FBRTK SPDBRG IMP SYS W/ BC SWVLK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
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 7/30/2025, an fda medwatch notification was received via email.A facility representative reported that the tip of an anchor from an ar-2600fsb-1 fibertak speedbridge implant system broke.The anchor applicator was removed, and the break was visualized.The broken tip was successfully retrieved from the patient¿s shoulder intact.It was matched to the broken anchor, and all pieces were confirmed to be accounted for.This was discovered during an rcr procedure on (b)(6) 2025.
Event or Problem Description
Additional information was received on 08/14/2025: specifically, the 4.75 mm knotless biocomposite swivelock sp anchor from the ar-2600fsb-1 fibertak speedbridge implant system broke during the procedure.The case was completed using additional readily available implants, resulting in no delay in case progression or completion.There was no report of additional anesthesia administered.The part number of the implant used to complete the case is unknown.
Additional Manufacturer Narrative
Additional information: b5, g3.
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 most likely cause for the reported failure can be attributed to user error of the device due to misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: FBRTK SPDBRG IMP SYS W/ BC SWVLK
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 22815941
• Report Number: 1220246-2025-03515
• Device Sequence Number: 21008480
• Product Code: MBI
• UDI-Device Identifier: 00888867429857
• UDI-Public: (01)00888867429857(11)240108(17)271231(10)15190350
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K222263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,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: FBRTK SPDBRG IMP SYS W/ BC SWVLK
• Device Catalogue Number: AR-2600FSB-1
• Device Lot Number: 15190350
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 08/14/2025; 10/17/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 08/27/2025; 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown