MAUDE Adverse Event Report: ARTHREX, INC. IMPL SYS,CMC MINI T-ROPE,1.1 MM; WASHER, BOLT, NUT

Model Number IMPL SYS,CMC MINI T-ROPE,1.1 MM

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2024

Event Type  malfunction  

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.

Event Description

On 01/24/2024, it was reported by a sales representative via (b)(4) that an ar-8919ds mini tightrope crimp holding the wire broke when using short passing wire to pull tightrope through tunnel.This occurred during use in a case with no patient effect.

• Brand Name: IMPL SYS,CMC MINI T-ROPE,1.1 MM
• Type of Device: WASHER, BOLT, NUT
• 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: 18711154
• MDR Text Key: 335469951
• Report Number: 1220246-2024-00986
• Device Sequence Number: 1
• Product Code: HTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140328
• 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: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMPL SYS,CMC MINI T-ROPE,1.1 MM
• Device Catalogue Number: AR-8919DS
• Device Lot Number: 15155334
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/17/2023
• 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