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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2021

Event Type  malfunction  

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 complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user error of the device due to user-applied mechanical forces.

Event Description

On (b)(6) 2021, it was reported by a sales representative via e-mail that a ar-2600sbs-10 speed bridge disengaged.This occurred on (b)(6) 2021 during a procedure when the handle of the disposable punch disengaged from the metal spear during insertion to create a hole for the anterior medial anchor.The spear was removed using vice grips since the handle spun independently off the metal shaft.The case was completed using a reusable punch from an in house shoulder tray.There was no patient effect reported.Additional information requested.Additional information provided on 12/14/2021 : the case was completed using a standard silver punch from the shoulder tray.The bone quality of the patient was above average.Additional information provided on 12/14/2021 : a rotator cuff repair was being performed.

• 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: 19192013
• MDR Text Key: 341253566
• Report Number: 1220246-2024-02458
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• 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
• Device Lot Number: 14589171
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1