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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 Material Frayed (1262)
Patient Problem Insufficient Information (4580)
Event Date 01/13/2022
Event Type  malfunction  
Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device is not expected to be returned for evaluation. The probable cause of the event could not be determined from the information available and without device evaluation. As no further investigation was able to be performed no change in harm was identified.
 
Event Description
On 1/13/2022, it was reported by a sales representative via sems that a 3. 0 hybrid val kruelock screw began to fray and a thin wire-like material came out of it when it was being inserted. This was discovered during a procedure.
 
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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 Key13621150
MDR Text Key289077204
Report Number1220246-2022-04535
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141735
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 02/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received01/13/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Type of Device Usage Initial

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