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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 Activation, Positioning or SeparationProblem (2906); Mechanical Jam (2983)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 05/28/2018
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 additional information is received.

 
Event Description

It was reported that the trigger got stuck during the surgery on universal modular electric/battery double trigger handpiece, part number 89-8507-400-00, serial number (b)(4). The surgery delay was 45 minutes and the patient was under anesthesia. The reason of the delay was the time to sterilize another device. There was no additional harm or injury to patient/operator reported.

 
Manufacturer Narrative

Modular electric/battery double trigger handpiece, serial number (b)(4) was not returned for complaint investigation. Therefore, the device could not be visually inspected in an effort to confirm the defect.   design history record review was performed and no issue was discovered during the manufacturing process that could explain the defect reported.   a follow-up medwatch will be submitted if the product is returned or if additional information is received.

 
Event Description

It was reported that the trigger got stuck during the surgery on universal modular electric/battery double trigger handpiece, part number 89-8507-400-00, serial number (b)(4). The surgery delay was 45 minutes and the patient was under anesthesia. The reason of the delay was the time to sterilize another 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 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 Key7644891
MDR Text Key112547659
Report Number0008031000-2018-00020
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeKE
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,Followup
Report Date 05/14/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/28/2018
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 Number5009123
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/16/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/05/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/14/2016
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: 06/28/2018 Patient Sequence Number: 1
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