MAUDE Adverse Event Report: ARTHREX, INC. CLAV FRAC PLT,CENTRAL THIRD,LFT,SS; WASHER, BOLT, NUT

Model Number CLAV FRAC PLT,CENTRAL THIRD,LFT,SS

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 11/02/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not received for evaluation and no photo was provided; complaint not confirmed.The most likely probable cause of the event is attributed to a patient specific event.

Event Description

It was reported by a legal representative that a patient had a clavicle surgery in 2017 at new york hospital.The representative reported that the records indicated that a ¿9 hole plate¿ ¿arthrex plate¿ was used for a right clavicle surgery and stated that the implant log was hand written and stated ¿ar -2652cl or 26526l¿.The most likely part number is believed to be the ar-2652 cl 8 hole plate.No lot number was provided.The representative further reported that post operatively the patient treated with a massage therapist and the services provided caused issues with the clavicle plate that was implanted.It was unknown what those issues were or if a revision surgery took place.To date, we have not received any further information.

• Brand Name: CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
• 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: emily shafer ; 8009337001
• MDR Report Key: 18276088
• MDR Text Key: 330703002
• Report Number: 1220246-2023-09220
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143139
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
• Device Catalogue Number: AR-2652CL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2021
• 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