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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, 85 MM, INCLUDING SET SCREW 10.5MM LAG SCREW 85MM LENGTH TI-6AL-4V

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ZIMMER GMBH ZNN, CMN LAG SCREW, 10.5 MM, 85 MM, INCLUDING SET SCREW 10.5MM LAG SCREW 85MM LENGTH TI-6AL-4V Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 12/04/2018
Event Type  Injury  
Manufacturer Narrative
The manufacturer received document for review. The manufacturer did not receive the device for investigation. As no lot number was provided, the device history records could not be reviewed. 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
During surgery two znn lag screw got damaged. The surgery was delayed by 40 minutes.
 
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Brand NameZNN, CMN LAG SCREW, 10.5 MM, 85 MM, INCLUDING SET SCREW
Type of Device10.5MM LAG SCREW 85MM LENGTH TI-6AL-4V
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 Key8177927
MDR Text Key130787798
Report Number0009613350-2018-01265
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,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47-2485-085-10
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/09/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/19/2018 Patient Sequence Number: 1
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