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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; UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE
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ZIMMER SURGICAL S.A. UNIVERSAL MODULAR ELECTRIC/BATTERY/DOUBLE; UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE Back to Search Results
Catalog Number 89-8507-400-00
Device Problem Failure to Shut Off (2939)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/01/2014
Event Type  malfunction  
Event Description
It was reported that while universal modular electric/battery double trigger handpiece during the tha intervention, the surgeon intended to stop the handpiece by simply releasing the finger from the trigger.The handpiece continued in action and could only been shut down by bringing the handpiece safety trigger in safe-off position.There was no patient harm or delay reported, and the procedure was completed with an alternate device.
 
Manufacturer Narrative
The device was returned to the manufacturer; however the device 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 outes, geneva
SZ 
Manufacturer Contact
katheleen smith
chemin pre fleuri 3
plan les outes, geneva CH-12-28
SZ   CH-1228
3303438801
MDR Report Key3832881
MDR Text Key4503964
Report Number8031000-2014-00149
Device Sequence Number1
Product Code GEY
Combination Product (y/n)N
Reporter Country CodeSZ
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 02/19/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2014
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 Manufacturer02/26/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/19/2014
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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