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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH CMN FEMORAL NAIL, CCD 125, RIGHT, 11.5 MM, 21.5 CM ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

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ZIMMER GMBH CMN FEMORAL NAIL, CCD 125, RIGHT, 11.5 MM, 21.5 CM ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS Back to Search Results
Model Number N/A
Device Problem Difficult To Position (1467)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/02/2018
Event Type  malfunction  
Manufacturer Narrative
The manufacturer did not receive devices for review. X-rays or other source documents were not provided for review. Where lot numbers were received for the device, the device history records were reviewed and found to be conforming. A cause for this specific event cannot be ascertained from the information provided. Additional information has been requested and is currently not available. As soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted. (b)(4).
 
Event Description
It was reported that the cmn femoral nail could not be implanted during surgery on (b)(6) 2018. No other information is available at that time.
 
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Brand NameCMN FEMORAL NAIL, CCD 125, RIGHT, 11.5 MM, 21.5 CM
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 Key7608841
MDR Text Key111326017
Report Number0009613350-2018-00635
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
PK091566
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 11/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47-2493-210-11
Device Lot Number2940153
Other Device ID Number00889024298842
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/23/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2018
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: 06/18/2018 Patient Sequence Number: 1
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