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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL SA UNIVERSAL MODULAR ELECTRIC / BATTERY DOUBLE TRIGGER HANDPIECE

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ZIMMER SURGICAL SA UNIVERSAL MODULAR ELECTRIC / BATTERY DOUBLE TRIGGER HANDPIECE Back to Search Results
Catalog Number 89-8507-400-00
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problem No Information (3190)
Event Date 11/13/2018
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 or if any additional information is received.

 
Event Description

It was reported that the electric/battery double trigger handpiece part number 89-8507-400-00, serial number (b)(4) would not turn on during surgery. It was reported that a few minutes of delay occured with the indication that this delay was higher to 30 minutes due to the time needed to change the device. No additional information was provided. There was no other harm or injury to patient/operator reported.

 
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Brand NameUNIVERSAL MODULAR ELECTRIC / BATTERY DOUBLE TRIGGER HANDPIECE
Type of DeviceUNIVERSAL MODULAR ELECTRIC / BATTERY DOUBLE TRIGGER HANDPIECE
Manufacturer (Section D)
ZIMMER SURGICAL SA
3, ch. du pre fleuri
plan-les-ouates, geneva 1228
SZ 1228
Manufacturer (Section G)
ZIMMER SURGICAL SA
3, ch. du pre fleuri
plan-les-ouates, geneva 1228
SZ 1228
Manufacturer Contact
christina arnt
56 e. bell drive
warsaw, IN 46582
5745273773
MDR Report Key8202257
MDR Text Key131582790
Report Number0008031000-2018-00030
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeUS
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 01/17/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/28/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number89-8507-400-00
Device LOT Number5005466
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/07/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/08/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/05/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 12/28/2018 Patient Sequence Number: 1
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