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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 Break (1069); Loss of Power (1475)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2014
Event Type  malfunction  
Event Description
It was reported that during surgery the zimmer universal modular electric/battery double trigger handpiece was braking during drilling and oscillating and had not power even after changing the battery.There was no pt harm or delay reported.
 
Manufacturer Narrative
The device was not returned to the mfr; 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
SZ 
Manufacturer Contact
kathleen smith
chemin pre fleuri 3
plan les ouates
geneva CH-12-28
SZ   CH-1228
3303438801
MDR Report Key3823812
MDR Text Key4402362
Report Number8031000-2014-00089
Device Sequence Number1
Product Code GEY
Combination Product (y/n)N
Reporter Country CodePL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Unknown
Type of Report Initial
Report Date 01/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2014
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 Manufacturer02/05/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received01/23/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
UNIVERSAL KEY CHUCK ATTACHMENT W/KEY,; UNIVERSAL OSCILLATING SAW ATTACHMENT, SN (B)(4); 1000RMP, SN (B)(4)
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