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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 Electrical /Electronic Property Problem (1198); Mechanical Problem (1384); Intermittent Loss of Power (4016)
Patient Problem No Information (3190)
Event Date 05/08/2019
Event Type  Injury  
Manufacturer Narrative
Complaint number (b)(4). 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 universal modular electric/battery double trigger handpiece part number 89-8507-400-00 serial number (b)(4) works intermittently, sometimes it works, sometimes it stops. The safety lock bottom locked in one position. The event occurred during knee arthroplasty. An extension of surgery of 60 minutes was reported due to the time needed to replace the device. The patient was under anesthesia at the time of the delay. 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
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 Key8854263
MDR Text Key153062057
Report Number0008031000-2019-00017
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeMX
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 11/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number89-8507-400-00
Device Lot Number5011276
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/04/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/02/2019 Patient Sequence Number: 1
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