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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL SA WIREDRIVER MIC-MTRC 1-4MM; SAW, POWERED, AND ACCESSORIES

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ZIMMER SURGICAL SA WIREDRIVER MIC-MTRC 1-4MM; SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number N/A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).G2- france.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
 
Event Description
It was reported that the wire driver no longer holds the wires securely.This event is related to a malfunction that could potentially lead to serious injury.However, in this case no patient harm or further outcome was reported.Attempts have been made and all additional information received has been included in this report.
 
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Brand Name
WIREDRIVER MIC-MTRC 1-4MM
Type of Device
SAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
ZIMMER SURGICAL SA
3, ch. du pre fleuri
1228 plan-les-ouates
geneva CH-12 28
SZ  CH-1228
Manufacturer (Section G)
ZIMMER SURGICAL SA
3, ch. du pre fleuri
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 Key18362460
MDR Text Key330938468
Report Number0008031000-2023-00081
Device Sequence Number1
Product Code HAB
UDI-Device Identifier889024354951
UDI-Public(01)889024354951
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number89-8509-451-41
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/24/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient SexPrefer Not To Disclose
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