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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. DEPTH GUIDE, MINI GAUGE, DEPTH

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ARTHREX, INC. DEPTH GUIDE, MINI GAUGE, DEPTH Back to Search Results
Model Number DEPTH GUIDE, MINI
Device Problems Fracture (1260); Device Slipped (1584)
Patient Problem Insufficient Information (4580)
Event Date 03/23/2021
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.
 
Event Description
It was reported that the top part of the depth guide fell off when the surgeon went to measure the drill hole for an implant. The tip was removed from the patient and the distal radius fracture case was completed.
 
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Brand NameDEPTH GUIDE, MINI
Type of DeviceGAUGE, DEPTH
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 Key11648182
MDR Text Key247538920
Report Number1220246-2021-02878
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,Followup,Followup
Report Date 07/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDEPTH GUIDE, MINI
Device Catalogue NumberAR-13120G-2
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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