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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL SA UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE TRIGGER HANDPIECE UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLETRIGGER HANDPIECE

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ZIMMER SURGICAL SA UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE TRIGGER HANDPIECE UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLETRIGGER HANDPIECE Back to Search Results
Catalog Number 89-8507-400-10
Device Problems Complete Blockage (1094); Failure to Auto Stop (2938)
Patient Problem No Information (3190)
Event Date 11/12/2020
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 sent if the product is returned or if additional information is received.

 
Event Description

It was reported that the universal modular electric/battery single trigger handpiece part number 89-8507-400-10 serial number (b)(4) does not stop, the trigger is blocked. The event occurred during surgery. An extension of surgery of 60 minutes was reported 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 SINGLE TRIGGER HANDPIECE
Type of DeviceUNIVERSAL MODULAR ELECTRIC/BATTERY SINGLETRIGGER 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
plan-les-ouates, geneva 1228
SZ 1228
Manufacturer Contact
christina arnt
56 e. bell drive
warsaw, IN 46582
5745273773
MDR Report Key10913793
MDR Text Key218510881
Report Number0008031000-2020-00010
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
Type of Report Initial
Report Date 11/27/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/27/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number89-8507-400-10
Device LOT Number5008029
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/13/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/12/2016
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: 11/27/2020 Patient Sequence Number: 1
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