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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH ZNN, CMN LAG SCREW, 10.5 MM, 105 MM INCLUDING SET SCREW ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

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ZIMMER GMBH ZNN, CMN LAG SCREW, 10.5 MM, 105 MM INCLUDING SET SCREW ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS Back to Search Results
Model Number N/A
Device Problem Break (1069)
Patient Problem Injury (2348)
Event Date 11/04/2016
Event Type  Injury  
Manufacturer Narrative
The manufacturer did not receive the device for investigation. No surgical report was provided for review. X-rays were received and will be reviewed within the investigation process. Where lot number were received for the devices, the devices history records were reviewed and found to be conforming. A cause for this specific event cannot be ascertained from the information provided. As soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted. Zimmer's reference number of this file is (b)(4).
 
Event Description
It was reported that the patient had a znn, cmn lag screw, 10. 5 mm, 105 mm implanted on (b)(6) 2016. On (b)(6) 2016, the patient reportedly fell and heard a pop. X-rays showed that the nail had fractured at the lag screw junction. All components were removed and revised on (b)(6) 2016. Note: this is a split case with zimmer inc, (b)(4).
 
Manufacturer Narrative
Trend analysis: no trend identified. Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended. Event summary: it was reported that the patient had a fall and heard a pop. The x-rays showed a broken nail. Review of received data: three x-rays were received dated (b)(6) 2016. On the x-rays it can be seen that the nail is broken through the hole for the lag screw. In addition it is visible that the femur bone is re-fractured. Devices analysis: the broken nail, lag screw and the set screw were returned for investigation. The visual examination sows that the nail was broken through the lag screw hole. The surface of the lag screw hole shows also some deformations at the contact points with the lag screw where the forces are transmitted. The fracture surface characterized by beach lines depict the fatigue character of the fracture. On both fracture surfaces no material defects that could have triggered the fracture could be detected. The lag screw shows some polished areas and damages in the middle part around the grooves. The set screw has a damaged tip, which is compatible with the contact of a lag screw groove. Review of product documentation: the compatibility check was performed and showed that the product combination was approved by zimmer biomet. Conclusion summary: it was reported that the patient had a fall and heard a pop. The taken x-rays shows a breakage of the nail. The visual examination of the returned products indicates that no material defects that could have triggered the fracture could be detected. Based on the given information and the results of the investigation, we could identify a root cause for this issue. The nail was broken due to patient fall. The need for further corrective measures is not indicated and zimmer (b)(4) considers this case as closed. (b)(4).
 
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Brand NameZNN, CMN LAG SCREW, 10.5 MM, 105 MM INCLUDING SET SCREW
Type of DeviceZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
Manufacturer (Section D)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer (Section G)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer Contact
kevin escapule
1800 west center street
warsaw, IN 46580
8006136131
MDR Report Key6180712
MDR Text Key62596666
Report Number0009613350-2016-01448
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 Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2020
Device Model NumberN/A
Device Catalogue Number47-2485-105-10
Device Lot Number2794466
Other Device ID Number00889024298460
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/28/2015
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/16/2016 Patient Sequence Number: 1
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