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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW, 1.4X8MM, CORTICAL, TI PLATE, FIXATION, BONE

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ARTHREX, INC. LOW PROFILE SCREW, 1.4X8MM, CORTICAL, TI PLATE, FIXATION, BONE Back to Search Results
Model Number LOW PROFILE SCREW, 1.4X8MM, CORTICAL, TI
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 03/09/2022
Event Type  malfunction  
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.
 
Event Description
On 3/30/2022, it was reported by a sales representative via email that (2) ar-18714-08 low profile screw head broke off. The screw head was removed and the body remains implanted in the patient. This was discovered during a phalanx orif procedure on (b)(6) 2022.
 
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Brand NameLOW PROFILE SCREW, 1.4X8MM, CORTICAL, TI
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 Key14135702
MDR Text Key296781976
Report Number1220246-2022-04743
Device Sequence Number1
Product Code HRS
UDI-Device Identifier00888867303874
UDI-Public00888867303874
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191326
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 04/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberLOW PROFILE SCREW, 1.4X8MM, CORTICAL, TI
Device Catalogue NumberAR-18714-08
Was Device Available for Evaluation? No
Date Manufacturer Received03/30/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Type of Device Usage Initial

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