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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHO DEVELOPMENT CORP. PRIMA HIP SCREW; 2.4MM GUIDE WIRE, 12 IN
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ORTHO DEVELOPMENT CORP. PRIMA HIP SCREW; 2.4MM GUIDE WIRE, 12 IN Back to Search Results
Model Number 280-0001
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/27/2015
Event Type  malfunction  
Event Description
A guide wire broke off in the bone while preparing for placement of a femoral nail.A 2.4mm guide wire broke between the lateral cortex and the guide wire when the surgeon tried to adjust the direction/angle of the guide wire.Drilling was pursued over the remaining piece in the femur and the drill was manually pulled out using a t-handle.The remaining piece came along with the drill, so there was no harm to the patient.
 
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Brand Name
PRIMA HIP SCREW
Type of Device
2.4MM GUIDE WIRE, 12 IN
Manufacturer (Section D)
ORTHO DEVELOPMENT CORP.
draper UT
Manufacturer Contact
mike ensign
12187 south business park dr.
draper, UT 84020
8015539991
MDR Report Key4620314
MDR Text Key5659493
Report Number1722511-2015-00005
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 03/10/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number280-0001
Device Catalogue Number280-0001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/10/2015
Initial Date FDA Received03/18/2015
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? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age75 YR
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