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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. HIP DISTRACTION SYSTEM APPARATUS, TRACTION, NON-POWERED

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ARTHREX, INC. HIP DISTRACTION SYSTEM APPARATUS, TRACTION, NON-POWERED Back to Search Results
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/23/2019
Event Type  malfunction  
Event Description
Hip distractor arm broke before first case. The substitute distractor arm worked for the first case but on the 2nd patient, dr. Not able to get enough distraction on the hip to do the procedure effectively. The 2nd patient's procedure was cancelled after being intubated and attempt at positioning with distractor.
 
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Brand NameHIP DISTRACTION SYSTEM
Type of DeviceAPPARATUS, TRACTION, NON-POWERED
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside blvd
naples FL 34108
MDR Report Key9128842
MDR Text Key160364366
Report Number9128842
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/30/2019
Event Location Hospital
Date Report to Manufacturer09/27/2019
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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