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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. PERIPHERAL SCREW DEPTH GAUGE
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ARTHREX, INC. PERIPHERAL SCREW DEPTH GAUGE Back to Search Results
Model Number PERIPHERAL SCREW DEPTH GAUGE
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 02/14/2024
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 02/14/2024, it was reported by a sales representative via (b)(4) that a peripheral screw depth gauge, ar-9629, has a broken tip.Reporter has no further information.
 
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Brand Name
PERIPHERAL SCREW DEPTH GAUGE
Type of Device
DEPTH GAUGE
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
jared engle
8009337001
MDR Report Key18817413
MDR Text Key336672314
Report Number1220246-2024-01243
Device Sequence Number1
Product Code HTJ
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 Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 03/01/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPERIPHERAL SCREW DEPTH GAUGE
Device Catalogue NumberAR-9629
Device Lot Number45551902
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/14/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/01/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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