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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 Problems Mechanical Problem (1384); Therapeutic or Diagnostic Output Failure (3023); Handpiece (3067)
Patient Problems Patient Problem/Medical Problem (2688); No Information (3190)
Event Date 03/23/2019
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 additional information is received.

 
Event Description

It was reported that the universal modular electric/battery double trigger handpiece part number 89-8507-400-00 serial number (b)(4) "did not work despite the battery change and the cable plugging". An extension of surgery between 30 minutes and 1 hour was reported and the patient was under anesthesia. The extension of surgery is due to the time needed to replace the device. There was no additional 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
chemin du pré fleuri, 3
plan-les-ouates, geneva CH-12 28
SZ CH-1228
Manufacturer (Section G)
ZIMMER SURGICAL SA
chemin du pré 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 Key8513469
MDR Text Key141903836
Report Number0008031000-2019-00014
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
Remedial Action Repair
Type of Report Initial,Followup
Report Date 07/08/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/15/2019
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 Number5005618
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/14/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/14/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/11/2014
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: 04/15/2019 Patient Sequence Number: 1
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