MAUDE Adverse Event Report: ARTHREX, INC. DISTAL CLAVICLE PLATE, 8 HOLE, RIGHT, SS; PLATE, FIXATION, BONE

Model Number	DISTAL CLAVICLE PLATE, 8 HOLE, RIGHT, SS
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2020
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.
Event or Problem Description
It was reported that the patient underwent a procedure where a distal clavicle plate, ar-2657dr, was implanted into their right shoulder.At some point after the procedure, the plate broke and the patient underwent a revision procedure on (b)(6) 2020 where a second distal clavicle plate, ar-2657dr, was implanted.The explanted broken plate was discarded.

• Brand Name: DISTAL CLAVICLE PLATE, 8 HOLE, RIGHT, SS
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10482492
• Report Number: 1220246-2020-02116
• Device Sequence Number: 1218554
• Product Code: HRS
• UDI-Device Identifier: 00888867027534
• UDI-Public: 00888867027534
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K143139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/02/2020

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: DISTAL CLAVICLE PLATE, 8 HOLE, RIGHT, SS
• Device Catalogue Number: AR-2657DR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 09/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other