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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH Z NAIL CPM 10MMX21.5CM 130 L ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

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ZIMMER GMBH Z NAIL CPM 10MMX21.5CM 130 L ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Information (3190)
Event Date 01/03/2019
Event Type  Injury  
Manufacturer Narrative
The manufacturer did not receive x-rays, or other source documents for review. Device history record (dhr) was reviewed and no discrepancies were found. 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. (b)(4).
 
Event Description
It was reported that a implant fractured. Attempts to obtain additional information have been made; however, no more is available.
 
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Brand NameZ NAIL CPM 10MMX21.5CM 130 L
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 Key8361380
MDR Text Key136853018
Report Number0009613350-2019-00086
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K091566
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47-2493-213-10
Device Lot Number2935201
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/27/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/16/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/05/2018
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

Patient Treatment Data
Date Received: 02/22/2019 Patient Sequence Number: 1
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