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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL SA MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE
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ZIMMER SURGICAL SA MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE Back to Search Results
Catalog Number 89-8507-400-00
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/18/2017
Event Type  Injury  
Manufacturer Narrative
Upon receipt, it was confirmed that the device failed at integrity test at level of motor screws 103201 and battery support screws. However, the reported event was not confirmed during the diagnosis. The motor screws 103201 and the battery support were replaced. The controller board, trigger/controller boards wire with wedges, motor wire kit, heat shrink, screw 302170, washer 301010, and seals were replaced as precaution. After repair, the device was tested as per internal processes and it was returned to the customer.
 
Manufacturer Narrative
The device was returned to manufacturer but it was not diagnosed at the time of this report. A follow-up medwatch will be submitted once the investigation is completed.
 
Event Description
It was reported that the modular electric/battery double trigger handpiece (serial number (b)(4)) does not function correctly. The surgery delay was between 30 and 60 minutes. The surgery was completed with another device. There was no additional harm or injury to patient/operator reported.
 
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Brand NameMODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE
Type of DeviceMODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE
Manufacturer (Section D)
ZIMMER SURGICAL SA
3, chemin du pre fleuri
plan-les-ouates, geneva CH-12 28
SZ CH-1228
Manufacturer (Section G)
ZIMMER SURGICAL SA
3, ch. du pre fleuri
plan-les-ouates, geneva CH-12 28
SZ CH-1228
Manufacturer Contact
christina arnt
56 e. bell drive
warsaw, IN 46582
5745273773
MDR Report Key6643219
MDR Text Key247046896
Report Number0008031000-2017-00010
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeFR
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
Report Date 08/31/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number89-8507-400-00
Device Lot Number5003112
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/21/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/15/2017 Patient Sequence Number: 1
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