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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 Inoperable (1663)
Patient Problem No Code Available (3191)
Event Date 02/23/2017
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 the universal modular electric/battery double trigger handpiece stopped and doesn't function anymore. The surgery delay was between 31 and 60 minutes. The surgery was completed with another device. There was no additional harm or injury to patient/operator reported.

 
Manufacturer Narrative

Universal modular electric/battery double trigger handpiece, serial number (b)(4), was returned for complaint investigation. Visual and functional tests were performed. Upon receipt, it was confirmed that the motor was seized. Besides, the trigger board connector and the trigger/controller boards wire were defective. The event reported by the customer was confirmed. As a result the motor, the trigger board (including the connector) and the trigger/controller boards wire were replaced. After repair, the product was tested and it was returned to the customer. Another follow-up medwatch will be submitted if new information is available.

 
Manufacturer Narrative

Universal modular electric/battery double trigger handpiece, serial number (b)(4), was returned for complaint investigation. Visual and functional tests were performed. Upon receipt, it was confirmed that the motor was seized. Besides, the trigger board connector and the trigger/controller boards wire were defective. The event reported by the customer was confirmed. As a result the motor, the trigger board (including the connector) and the trigger/controller boards wire were replaced. After repair, the product was tested and it was returned to the customer. Additional information was received: a device backup was used to complete the surgery.

 
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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
chemin du pre fleuri, 3
plan-les-ouates, geneva CH-12 28
SZ CH-1228
Manufacturer (Section G)
ZIMMER SURGICAL SA
chemin du pre fleuri, 3
plan-les-ouates, geneva CH-12 28
SZ CH-1228
Manufacturer Contact
christina arnt
56 e. bell drive
warsaw, IN 46582
5745273773
MDR Report Key6430875
MDR Text Key70741743
Report Number0008031000-2017-00004
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
Type of Report Initial,Followup,Followup
Report Date 07/25/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/24/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number89-8507-400-00
Device LOT Number5005919
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/16/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/26/2015
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: 03/24/2017 Patient Sequence Number: 1
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