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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. TORPEDO ACCESSORIES, ARTHROSCOPIC

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ARTHREX, INC. TORPEDO ACCESSORIES, ARTHROSCOPIC Back to Search Results
Model Number AR-8400TD
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/16/2017
Event Type  malfunction  
Event Description
The tip of the device broke off in the patient's knee area. The surgeon was able to remove the piece. No injury to patient.
 
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Brand NameTORPEDO
Type of DeviceACCESSORIES, ARTHROSCOPIC
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside blvd.
naples FL 34108
MDR Report Key6841453
MDR Text Key84640711
Report Number6841453
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 08/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAR-8400TD
Device Lot Number10110318
Other Device ID Number4.0MM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/17/2017
Event Location Hospital
Date Report to Manufacturer08/17/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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