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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); Blocked Connection (2888); Protective Measures Problem (3015); Handpiece (3067)
Patient Problem No Information (3190)
Event Date 10/16/2018
Event Type  Injury  
Manufacturer Narrative

Zimmer biomet complaint (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 any 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) was blocked and was not functional. During the partial hip replacement surgery, a delay of 84 minutes was reported. The reason for the delay was due to time needed for the diagnosis of the handpiece and search of the replacement. The patient was under anesthesia at the time of the delay. A different handpiece was used to complete the procedure. 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 Key8234696
MDR Text Key132764535
Report Number0008031000-2019-00002
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeMO
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 05/10/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/10/2019
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 Number5009773
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/19/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/10/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/25/2017
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: 01/10/2019 Patient Sequence Number: 1
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