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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PIONEER SURGICAL PIONEER SURGICAL CANNULATED SCREW, GUIDEWIRE; CANNULATED SCREW GUIDE WIRE
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PIONEER SURGICAL PIONEER SURGICAL CANNULATED SCREW, GUIDEWIRE; CANNULATED SCREW GUIDE WIRE Back to Search Results
Model Number 00-1147-092-00
Device Problem Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/25/2014
Event Type  malfunction  
Event Description
During a pelvic/si/acetabular fracture case, the guide wire got stuck inside the drill bit.The surgeon did not realize this took place and while continuing to advance the drill bit pushed the guidewire into the pelvic cavity.Surgery was completed using another drill bit and guide wire.The patient's condition is unknown.
 
Manufacturer Narrative
Device was not returned for evaluation.Pioneer surgical has worked with zimmer, our distributor of this system, to get more information but no more has been able to be gathered.
 
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Brand Name
PIONEER SURGICAL CANNULATED SCREW, GUIDEWIRE
Type of Device
CANNULATED SCREW GUIDE WIRE
Manufacturer (Section D)
PIONEER SURGICAL
375 river park circle
marquette MI 49855
Manufacturer Contact
dan nelson
375 river park circle
marquette, MI 49855
9062264489
MDR Report Key4176333
MDR Text Key5088816
Report Number1833824-2014-00013
Device Sequence Number1
Product Code HTN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K003496
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 07/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number00-1147-092-00
Device Catalogue NumberSAME
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/25/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
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