MAUDE Adverse Event Report: ARTHREX, INC. TKL SPDBRG IMP SYS W/ BC SWVLK & NDL; BIO SOFT TISSUE FIXATN FASTNR

Model Number TKL SPDBRG IMP SYS W/ BC SWVLK & NDL

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 01/26/2022

Event Type  malfunction  

Event Description

On 1/27/2022, it was reported by a sales representative via email that an ar-2600sbs-10 speedbridge implant system 4.75 swivelock, after being fully implanted, the locking mechanism came out when surgeon removed the inserter.This was discovered during a procedure on (b)(6) 2022.Additional information requested.

Manufacturer Narrative

This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation.

• Brand Name: TKL SPDBRG IMP SYS W/ BC SWVLK & NDL
• Type of Device: 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: 19110694
• MDR Text Key: 340721490
• Report Number: 1220246-2024-02028
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867369658
• UDI-Public: 00888867369658
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TKL SPDBRG IMP SYS W/ BC SWVLK & NDL
• Device Catalogue Number: AR-2600SBS-10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1