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
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1220246-2023-09220
• Device Sequence Number: 7152189
• Product Code: HRS
• UDI-Device Identifier: 00888867027428
• UDI-Public: 00888867027428
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/06/2023

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: CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
• Device Catalogue Number: AR-2652CL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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