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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW, 2.4 X 34MM, CORTICAL; PLATE, FIXATION, BONE
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ARTHREX, INC. LOW PROFILE SCREW, 2.4 X 34MM, CORTICAL; PLATE, FIXATION, BONE Back to Search Results
Model Number LOW PROFILE SCREW, 2.4 X 34MM, CORTICAL
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/06/2021
Type of Reportable Event Malfunction
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.If the device becomes available for evaluation, a follow-up report will be submitted.
 
Event or Problem Description
It was reported that during a procedure, the ar-18724-34 from mini cfs set popped through the plate when the surgeon was screwing it in the patient.The surgeon first used power and finished tightening by hand.No additional information provided.Additional information requested.
 
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Brand Name
LOW PROFILE SCREW, 2.4 X 34MM, CORTICAL
Common Device Name
PLATE, FIXATION, BONE
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key11991309
Report Number1220246-2021-03279
Device Sequence Number3564728
Product Code HRS
UDI-Device Identifier00888867314160
UDI-Public00888867314160
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K191344
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 06/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberLOW PROFILE SCREW, 2.4 X 34MM, CORTICAL
Device Catalogue NumberAR-18724-34
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/27/2021
Initial Report FDA Received Date06/14/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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