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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 Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2022
Event Type  malfunction  
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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 Key15042011
Report Number1220246-2022-05267
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 Company Representative
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 07/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/18/2022
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 Number01173203
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/01/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/15/2017
Is the Device Single Use? No
Type of Device Usage Initial

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