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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH ZIMMER NATURAL NAIL SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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ZIMMER GMBH ZIMMER NATURAL NAIL SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 47-2493-423-11
Device Problem Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/02/2019
Event Type  malfunction  
Event Description
Patient was undergoing surgery for a left intertrochanteric hip fracture. The guide pin was not centered in the intramedullary hip screw appropriately. Per the op note: "we then made a stab incision and the trocar and cannula were placed through the outrigger and against the lateral aspect of the femur. We then placed the guide pin in the center of the femoral head confirming to be in the correct position on ap and lateral radiographs with an excellent tip-to-apex distance. It did take us multiple attempts to get the guidewire in the correct position due to new instrumentation. I did partially ream over a previously placed guidewire, but after reaming, it was in poor position. I did have to reposition the guide pin after our initial reaming into the femoral head because of poor positioning into the femoral head. " per the incident report placed by the surgeon: "i had to make multiple passes into the femoral head with the guide pin and reamed with a reamer, then had to reposition the guide pin after reaming because the guide pin was not centered in the aperture for the lag screw. I am concerned, with her poor bone quality that the multiple passes into the femoral head in addition to reaming for the lag screw will increase her risk of cutout. " the surgeon stated "anytime there are more than 3 passes, there is an increased risk of the implant failing. Stated that he did 12 passes. Stated that the pin should be in the center and parallel, but that his came in obliquely. Concern is that the screw might cut the implant (i. E. Lag screw could fail and rip through the femoral head, and then the patient would need another surgery).
 
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Brand NameZIMMER NATURAL NAIL SYSTEM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
ZIMMER GMBH
56 east bell drive
warsaw IN 46581
MDR Report Key9664365
MDR Text Key177581350
Report Number9664365
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number47-2493-423-11
Device Catalogue Number47-2493-423-11
Device Lot Number2581665
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/07/2020
Event Location Hospital
Date Report to Manufacturer02/04/2020
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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