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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. DISTAL CLAVICLE PLATE, 8 HOLE, RIGHT, SS; PLATE, FIXATION, BONE
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ARTHREX, INC. DISTAL CLAVICLE PLATE, 8 HOLE, RIGHT, SS; PLATE, FIXATION, BONE Back to Search Results
Model Number DISTAL CLAVICLE PLATE, 8 HOLE, RIGHT, SS
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 02/04/2021
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 by the patient mother that while her son was playing baseball on (b)(6) 2021, ran for catch and hit a wall the ar-2657dr, plate in his shoulder snapped.Original surgery was (b)(6) 2021.Revision surgery scheduled for (b)(6) 2021.
 
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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 Key11392581
Report Number1220246-2021-02630
Device Sequence Number1166763
Product Code HRS
UDI-Device Identifier00888867027534
UDI-Public00888867027534
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K143139
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 03/01/2021
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? Yes
Operator of Device Health Professional
Device Model NumberDISTAL CLAVICLE PLATE, 8 HOLE, RIGHT, SS
Device Catalogue NumberAR-2657DR
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/10/2021
Initial Report FDA Received Date03/01/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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