MAUDE Adverse Event Report: ARTHREX, INC. SPEEDBRG IMP SYS W/BIO-COMP SWVLK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SPEEDBRG IMP SYS W/BIO-COMP SWVLK
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 2/5/2024, it was reported by a sales representative via email that an ar-2600sbs-4 speedbridge implant system had an issue.While using the blue swivlelock punch that comes with the kit, the blue plastic handle disassociated from the metal, resulting in the punch becoming stuck in the pilot hole due to the surgeon not being able to get the necessary torque/grip on the handle to remove.This resulted in the surgeon utilizing a pliers-like tool to grip the metal part of the punch and mallet it out.This was discovered during an unspecified procedure on (b)(6) 2024.Additional information provided 2/21/24: the procedure performed was a rotator cuff repair.The case was completed by using an ar-1927pb.The device was removed using a sterile pliers.No delay in the case.No additional anesthesia was administered.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided, including the device (if available and returned), pictures, videos, event descriptions, and any additional field information, arthrex concluded that the cause of the reported failure was a user error due to mishandling the device.The complaint allegation was not confirmed.The device was not received for evaluation, and the customer¿s attached picture does not provide evidence of the failure.

• Brand Name: SPEEDBRG IMP SYS W/BIO-COMP SWVLK
• 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: 18778164
• Report Number: 1220246-2024-01118
• Device Sequence Number: 15530704
• Product Code: MAI
• UDI-Device Identifier: 00888867027312
• UDI-Public: 00888867027312
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/04/2025

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: SPEEDBRG IMP SYS W/BIO-COMP SWVLK
• Device Catalogue Number: AR-2600SBS-4
• Device Lot Number: 15146937
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2023
• 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