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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. CLAV FRAC PLT,CENTRAL THIRD,RT,SS; PLATE, FIXATION, BONE
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ARTHREX, INC. CLAV FRAC PLT,CENTRAL THIRD,RT,SS; PLATE, FIXATION, BONE Back to Search Results
Model Number CLAV FRAC PLT,CENTRAL THIRD,RT,SS
Health Effect - Clinical Code Pain (1994)
Date of Event 12/13/2018
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 device was reported to have been discarded.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 needed a revision to replace the ar-2654cr clavicle plate with an ar-2653cr plate.The plate broke; per the patient, he woke up one day in pain and x-rays confirmed the plate had broken.Case was a clavicle orif; original date of surgery was (b)(6) 2018.Both the original case and the revision were done at the same facility with the same surgeon.
 
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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
MDR Report Key8247838
Report Number1220246-2019-00851
Device Sequence Number19230890
Product Code HRS
UDI-Device Identifier00888867027473
UDI-Public00888867027473
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K143139
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/15/2019
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 No Information
Device Model NumberCLAV FRAC PLT,CENTRAL THIRD,RT,SS
Device Catalogue NumberAR-2654CR
Device Lot Number5261824
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/27/2018
Initial Report FDA Received Date01/15/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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