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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. DRILL BIT, MINI AO, 1.2MM, CALIBRATED; BIT, DRILL
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ARTHREX, INC. DRILL BIT, MINI AO, 1.2MM, CALIBRATED; BIT, DRILL Back to Search Results
Model Number DRILL BIT, MINI AO, ¿1.2MM, CALIBRATED
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/14/2021
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-18700-14 and ar-18700-12 drill bits broke.The sales rep stated that the bars are catching.The case was completed without any adverse event.
 
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Brand Name
DRILL BIT, MINI AO, 1.2MM, CALIBRATED
Common Device Name
BIT, DRILL
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key11912013
Report Number1220246-2021-03182
Device Sequence Number3059826
Product Code HTW
UDI-Device Identifier00888867312678
UDI-Public00888867312678
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
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) 06/01/2021
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 NumberDRILL BIT, MINI AO, ¿1.2MM, CALIBRATED
Device Catalogue NumberAR-18700-12
Device Lot Number022040
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/14/2021
Initial Report FDA Received Date06/01/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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