MAUDE Adverse Event Report: ARTHREX, INC. CLAV FRAC PLT,CENTRAL THIRD,RT,SS; PLATE, FIXATION, BONE

Model Number	CLAV FRAC PLT,CENTRAL THIRD,RT,SS
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/11/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
On 3/23/2022, it was reported by a facility representative via medwatch mailed in letter that an ar-2653cr clavicle fracture plate was implanted in (b)(6) 2021.While patient was putting on a coat, the plate snapped in half.This occurred in (b)(6) 2022.Patient had a revision surgeon on (b)(6) 2022 and the plate was explanted.Lot number for plate is unknown and no further details have been provided.

• Brand Name: CLAV FRAC PLT,CENTRAL THIRD,RT,SS
• Common Device Name: PLATE, FIXATION, BONE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 14075081
• Report Number: 1220246-2022-04717
• Device Sequence Number: 2570268
• Product Code: HRS
• UDI-Device Identifier: 00888867027459
• UDI-Public: 00888867027459
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K143139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CLAV FRAC PLT,CENTRAL THIRD,RT,SS
• Device Catalogue Number: AR-2653CR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 04/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown