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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. CLAV FRAC PLT,CENTRAL THIRD,LFT,SS; PLATE, FIXATION, BONE
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ARTHREX, INC. CLAV FRAC PLT,CENTRAL THIRD,LFT,SS; PLATE, FIXATION, BONE Back to Search Results
Model Number CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
Health Effect - Clinical Codes Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event 01/20/2021
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 that the patient was originally treated with an arthrex clavicle plate and 3.5mm cortex screws.Several months after the primary surgery, the screws eventually backed out; resulting in a non-union.The patient was revised on (b)(6) 2021 using an autograft from the illiac crest, an anterior 2.7mm locking plate and a 3.5mm lcp superior clavicle plate.
 
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Brand Name
CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
Common Device Name
PLATE, FIXATION, BONE
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key11591150
Report Number1220246-2021-02797
Device Sequence Number14220895
Product Code HRS
UDI-Device Identifier00888867027480
UDI-Public00888867027480
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K143139
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2021
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 03/30/2021
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? No
Operator of Device Health Professional
Device Model NumberCLAV FRAC PLT,CENTRAL THIRD,LFT,SS
Device Catalogue NumberAR-2655CL
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/08/2021
Initial Report FDA Received Date03/30/2021
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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