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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN ZIMMER NATURAL NAIL SHORT NAIL TRAUMA PROSTHESIS

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ZIMMER, INC. UNKNOWN ZIMMER NATURAL NAIL SHORT NAIL TRAUMA PROSTHESIS Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Bone Fracture(s) (1870)
Event Type  Injury  
Manufacturer Narrative

This report will be amended when our investigation is complete.

 
Event Description

It is reported that a patient was revised due to a fracture.

 
Manufacturer Narrative

No product, part number, or lot number was returned for evaluation. The condition of the device could not be observed, and the device history record could not be reviewed. This device is used for treatment. Since no lot number was available no complaint history review could be conducted for the related lot and part number combination. Operative notes and post-operative notes were not available. The root cause of nail fracturing could not be concluded.

 
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Brand NameUNKNOWN ZIMMER NATURAL NAIL SHORT NAIL
Type of DeviceTRAUMA PROSTHESIS
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
carrie schneider
p.o. box 708
warsaw, IN 46581-0708
8006136131
MDR Report Key5771859
MDR Text Key48833406
Report Number0001822565-2016-02265
Device Sequence Number1
Product Code JDP
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/07/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/06/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 07/06/2016 Patient Sequence Number: 1
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