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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 Component Missing (2306)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
The manufacturer did not receive x-rays but received other source documents for review. The manufacturer did not receive the device for investigation. The device history records were reviewed and found to be conforming. Additional information has been requested and is currently not available. A cause for this specific event cannot be ascertained from the information provided. As soon as supplemental information becomes available, an updated report will be submitted. Zimmer biomet¿s reference number of this file is (b)(4).
 
Event Description
It was reported that during surgery it was found that there was no lag screw inside the package.
 
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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
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key8507530
MDR Text Key141741356
Report Number0009613350-2019-00212
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K091566
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47-2485-105-10
Device Lot Number2913859
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/21/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/10/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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