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U.S. Department of Health and Human Services

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

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ZIMMER SURGICAL SA MODULAR ELECTRIC/BATTERY SINGLE TRIGGER HANDPIECE Back to Search Results
Catalog Number 89-8507-400-10
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/04/2017
Event Type  Injury  
Manufacturer Narrative
Universal modular electric/battery single trigger handpiece, serial number (b)(4) was returned for complaint investigation. Visual and functional tests were performed. Upon receipt, it was confirmed that device was functional. However, a lack of glue around battery support screws was noticed. This defect cannot explain the issue reported by the customer. The defect reported by the customer ("not work") was not confirmed. As a repair, the battery support screws were replaced. Final tests were performed and device was returned to the customer.
 
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.
 
Event Description
It was reported that the modular electric/battery single trigger handpiece part number 89-8507-400-10 and serial number (b)(4) does not work. The surgery delay is unknown but was more than 30 minutes. There was no additional harm or injury to patient/operator reported.
 
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Brand NameMODULAR ELECTRIC/BATTERY SINGLE TRIGGER HANDPIECE
Type of DeviceMODULAR ELECTRIC/BATTERY SINGLE 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 Key7258568
MDR Text Key254796377
Report Number0008031000-2018-00005
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeCH
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 03/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number89-8507-400-10
Device Lot Number5007431
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/27/2015
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: 02/09/2018 Patient Sequence Number: 1
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