MAUDE Adverse Event Report: ARTHREX, INC. TKL SPDBRG IMP SYS W/ BC SWVLK & NDL; BONE FIXATION SCREW/PLATE

Model Number	TKL SPDBRG IMP SYS W/ BC SWVLK & NDL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/1/024, it was reported by a sales representative via phone that one of the blue swivelock anchor from an ar-2600sbs-11 knotless speedbridge implant system broke during insertion.The fragments were not removed.The case was completed using the rest of the knotless speedbridge kit and an individual anchor.This was discovered during an rcr procedure on (b)(6) 2024.The case was delayed more than fifteen minutes with additional anesthesia.Additional information received on 10/8/2024: the surgeon used a mallet lightly to impact the anchor.After the anchor broke, a snap was heard, as if the sutures had broken inside the eyelet.The sutures were jammed in the swivelock inserter and no longer sliding.The anchor remains in the patient.
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.Visual evaluation of the customer-provided pictures noted an ar-2600sbs-11 knotless speedbridge implant system broke.Refer to attachments.The complaint allegation is confirmed based on the customer-provided pictures.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: TKL SPDBRG IMP SYS W/ BC SWVLK & NDL
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: 20418327
• Report Number: 1220246-2024-08085
• Device Sequence Number: 20888528
• Product Code: MAI
• UDI-Device Identifier: 00888867369665
• UDI-Public: (01)00888867369665(11)240524(17)280430(10)15253508
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K193503
• 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): 08/19/2025

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: TKL SPDBRG IMP SYS W/ BC SWVLK & NDL
• Device Catalogue Number: AR-2600SBS-11
• Device Lot Number: 15253508
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2024
• 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