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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL SA MODULAR ELECTRIC/BATTERY SINGLE TRIGGER HANDPIECE
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ZIMMER SURGICAL SA MODULAR ELECTRIC/BATTERY SINGLE TRIGGER HANDPIECE Back to Search Results
Catalog Number 89-8507-400-10
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/13/2016
Event Type  Injury  
Manufacturer Narrative
The device was not returned to the manufacturer at the date of this report.A follow up medwatch will be submitted once the investigation is completed.
 
Event Description
It was reported that universal modular electric/battery single trigger handpiece did not work.The surgery was completed by another device.The surgery delay was between 1 and 2 hours because the new power system needed to be arranged to complete surgery.There were no harm or no injury to patient or operator.
 
Manufacturer Narrative
The universal modular electric/battery single trigger handpiece, serial number (b)(4) will not be returned for complaint investigation.Therefore, no visual inspection and no functional test of the device could be performed in an effort to confirm the defect.A device history records review was performed.No record of manufacturing issue was discovered that could explain the device malfunction.A follow-up medwatch will be submitted if the product is returned or if additional information is received.Device not returned.
 
Event Description
The adverse event reported was a delay of 2 hours in the surgery.No additional patient/operator injury was reported.
 
Manufacturer Narrative
The universal modular electric/battery single trigger handpiece, serial number (b)(4) was returned for complaint.Visual and functional tests were performed.Upon receipt, it was confirmed that the motor was noisy, the battery support was damaged and the trigger/controller boards wire was defective.The event reported by the customer was confirmed.As repair, the motor, the battery support and the trigger/controller boards were replaced with controller board.The product was returned to the customer.
 
Manufacturer Narrative
The universal modular electric/battery single trigger handpiece, serial number (b)(4) was returned for complaint.Visual and functional tests were performed.Upon receipt, it was confirmed that the motor was noisy, the battery support was damaged and the trigger/controller boards wire was defective.The event reported by the customer was confirmed.As repair, the motor, the battery support and the trigger/controller boards were replaced with controller board.New information was received: a back up was used to complete the surgery.The time to prepare it was the reason of the delay.
 
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Brand Name
MODULAR ELECTRIC/BATTERY SINGLE TRIGGER HANDPIECE
Type of Device
MODULAR ELECTRIC/BATTERY SINGLE TRIGGER HANDPIECE
Manufacturer (Section D)
ZIMMER SURGICAL SA
3, ch. du pre fleuri
1228 plan-les-ouates
geneva CH-12 28
SZ  CH-1228
Manufacturer Contact
cecile guiot
3, ch. du pre fleuri
1228 plan-les-ouates
geneva 
2706210600
MDR Report Key5607826
MDR Text Key44388705
Report Number0008031000-2016-00004
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 08/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number89-8507-400-10
Device Lot Number5005788
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/24/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/28/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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