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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. PLATE, FIXATION, BONE

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ARTHREX, INC. PLATE, FIXATION, BONE Back to Search Results
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 11/04/2021
Event Type  Injury  
Event Description
On (b)(6) 2022, it was reported by a patient via email that on (b)(6) 2021, an arthrex distal extremities plate was implanted on the patient's 5th metatarsal bone on the right foot. On (b)(6) 2021, the patient went for a post-operative appointment and an x-ray was taken which showed great recovery. The patient attended post-operative follow up appointments every two weeks. During one of the appointments, on (b)(6) 2021, the surgeon decided not to do an x-ray since the patient was doing well and walking great. A month later, on (b)(6) 2021, during the next appointment, an x-ray was which revealed the titanium plate had snapped in half. The patient underwent a revision surgery on (b)(6) 2021 and the plate was removed and a screw implanted. The plate part and lot number are unknown. It is also unknown if the screw that was implanted during the revision surgery on (b)(6) 2021 is an arthrex device. No further information has been given.
 
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.
 
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Brand NameUnknown Brand Name
Type of DevicePLATE, 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 Key13928452
MDR Text Key288893692
Report Number1220246-2022-04655
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052614
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 03/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received03/10/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/28/2022 Patient Sequence Number: 1
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