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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL S.A. UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE
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ZIMMER SURGICAL S.A. UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE Back to Search Results
Catalog Number 89-8507-400-00
Device Problems Partial Blockage (1065); Device Inoperable (1663)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/31/2014
Event Type  malfunction  
Event Description
It was reported that the universal modular electric/battery double trigger handpiece was blocked and did not function.There was no patient harm; however there was a delay in surgery for approximately 60 minutes.
 
Manufacturer Narrative
The device was returned to the manufacturer; however the investigation was not completed at the time of this report.A follow up medwatch will be submitted once the investigation is complete.
 
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Brand Name
UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE
Type of Device
UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE
Manufacturer (Section D)
ZIMMER SURGICAL S.A.
chemin pre fleuri 3
plan les ouates, geneva CH-1 228
SZ  CH-1228
Manufacturer Contact
kathleen smith
chemin pre fleuri 3
plan les ouates, geneva CH-12-28
SZ   CH-1228
3438801
MDR Report Key3820644
MDR Text Key4400701
Report Number8031000-2014-00212
Device Sequence Number1
Product Code GFA
Combination Product (y/n)N
Reporter Country CodeMO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number89-8507-400-00
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/24/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/24/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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