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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 Problems Device Inoperable (1663); Handpiece (3067)
Patient Problem No Code Available (3191)
Event Date 04/18/2017
Event Type  Injury  
Manufacturer Narrative

The device was not returned to the manufacturer at the date of this report. A follow-up medwatch wil be submitted once the investigation is completed.

 
Event Description

It was reported that the modular electric/battery single trigger handpiece, serial number (b)(4), stopped working during the surgery while the patient was under anesthesia. The surgery was delayed for 45 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 single trigger handpiece, serial number (b)(4) was returned for complaint investigation at zimmer (b)(4). Upon receipt, it was confirmed that the motor was seized and the device failed at the integrity test due to cracked battery support. No repair was performed since quotation was rejected. Device was recycled in zimmer premises.

 
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Brand NameMODULAR ELECTRIC/BATTERY SINGLE TRIGGER HANDPIECE
Type of DeviceMODULAR 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 (Section G)
ZIMMER SURGICAL SA
3, ch. du pre fleuri
1228 plan-les-ouates, geneva CH-12 28
SZ CH-1228
Manufacturer Contact
christina arnt
56 e. bell drive
warsaw, IN 46582
5745273773
MDR Report Key6776221
MDR Text Key82110523
Report Number0008031000-2017-00015
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeCO
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 12/12/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/09/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number89-8507-400-10
Device LOT Number5004050
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/08/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/24/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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