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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CMN FEMORAL NAIL, CCD 130, LEFT, 11.5 MM, 21.5 CM ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

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ZIMMER SWITZERLAND MANUFACTURING GMBH CMN FEMORAL NAIL, CCD 130, LEFT, 11.5 MM, 21.5 CM ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS Back to Search Results
Model Number N/A
Device Problems Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975); Appropriate Term/Code Not Available (3191)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/27/2020
Event Type  Injury  
Manufacturer Narrative
The manufacturer did not receive x-rays for review. Other source documents were received and will be reviewed as part of ongoing investigation. The manufacturer did not receive yet the device, however it is indicated by complainant that it will be returned 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. (b)(4).
 
Event Description
During surgery the nail present in the box was a 10mm instead of 11. 5mm as mentioned in the label. The box was found to be mislabeled as 11. 5mm and hence the surgery was delayed by 45-60 minutes.
 
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Brand NameCMN FEMORAL NAIL, CCD 130, LEFT, 11.5 MM, 21.5 CM
Type of DeviceZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
Manufacturer (Section D)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer (Section G)
ZIMMER SWITZERLAND MANUFACTURING 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 Key11129833
MDR Text Key225484390
Report Number0009613350-2021-00002
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091566
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47-2493-213-11
Device Lot Number3025629
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 Received05/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/03/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 01/07/2021 Patient Sequence Number: 1
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