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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. DRIVER, T10 HEXALOBE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
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ARTHREX, INC. DRIVER, T10 HEXALOBE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE Back to Search Results
Model Number DRIVER, T10 HEXALOBE
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/01/2022
Event Type  malfunction  
Event Description
On 10/18/2022, it was reported by medwatch via email that an ar-8944dh driver tip broke in the head of the screw.Broken piece was unable to be retrieved.This was discovered during an unspecified procedure on (b)(6) 2022.
 
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 Name
DRIVER, T10 HEXALOBE
Type of Device
INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
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 Key15743272
MDR Text Key307212331
Report Number1220246-2022-05707
Device Sequence Number1
Product Code MDM
UDI-Device Identifier00888867053045
UDI-Public00888867053045
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 11/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDRIVER, T10 HEXALOBE
Device Catalogue NumberAR-8944DH
Was Device Available for Evaluation? No
Date Manufacturer Received10/18/2022
Is the Device Single Use? No
Type of Device Usage Initial
Patient Sequence Number1
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