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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOFIX SRL CHIMAERA HIP FRACTURE SYSTEM FIXATION ROD

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ORTHOFIX SRL CHIMAERA HIP FRACTURE SYSTEM FIXATION ROD Back to Search Results
Model Number 193282
Device Problems Break (1069); Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)
Patient Problem No Code Available (3191)
Event Date 02/10/2018
Event Type  malfunction  
Event Description
Information provided stated that the surgeon had placed the screw in the wrong position. When trying to reposition the screw surgeon could not get a good x-ray. He removed the targeting arm and tried to freehand removal of the screw. The tip of the retention rod broke off inside the lag screw. The event resulted in a delay in the case. The lag screw with the tip remained in the patient. A revision surgery (date unknown) was performed to replace the chimaera with a hemi arthroplasty. The lag screw and tip of the retention rod were discarded at the hospital.
 
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Brand NameCHIMAERA HIP FRACTURE SYSTEM
Type of DeviceFIXATION ROD
Manufacturer (Section D)
ORTHOFIX SRL
via delle nazioni 9
bussolengo, verona 37012
IT 37012
MDR Report Key7441940
MDR Text Key105891225
Report Number2183449-2018-00010
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 04/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number193282
Device Lot Number1707942
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/17/2018
Distributor Facility Aware Date03/21/2018
Event Location Hospital
Date Report to Manufacturer04/18/2018
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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