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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 the battery support screw and the front face screw was noticed. These defects cannot explain the issue reported by the customer. The defect reported by the customer ("not work") was not confirmed. As a repair, glue was added around the battery support screw as well as the front face screw. The seals were replaced as they needed to be removed for the diagnosis of the device. After repair, the device passed final inspection and was returned to the customer.
 
Manufacturer Narrative
The complaint was initially reported by (b)(6) hospital, no additional contact information were received from initial reporter. The device was not yet 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, serial (b)(4) did not work. A delay in surgery of more than 30 minutes was reported but the exact duration of a delay time is unknown.
 
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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
1228 plan-les-ouates
geneva CH-12 28
SZ CH-1228
Manufacturer Contact
christina arnt
56 e. bell drive
warsaw, IN 46582
5745273773
MDR Report Key7218024
MDR Text Key164777762
Report Number0008031000-2018-00002
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
Type of Report Initial,Followup,Followup
Report Date 03/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number89-8507-400-10
Device Lot Number5007338
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/28/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/25/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 01/25/2018 Patient Sequence Number: 1
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