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

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).

• Brand Name: ZIMMER NATURAL NAIL SYSTEM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ZIMMER GMBH; 56 east bell drive; warsaw IN 46581
• MDR Report Key: 9664365
• MDR Text Key: 177581350
• Report Number: 9664365
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 47-2493-423-11
• Device Catalogue Number: 47-2493-423-11
• Device Lot Number: 2581665
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/07/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21170 DA