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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SPINE TORQUE LIMITING T-HANDLE; INSTINCT JAVA SYSTEM
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ZIMMER SPINE TORQUE LIMITING T-HANDLE; INSTINCT JAVA SYSTEM Back to Search Results
Catalog Number 046W1AN00650
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/15/2018
Event Type  malfunction  
Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference report 3003853072-2018-00008.
 
Event Description
It was reported that the torque limiting mechanism on a handle malfunctioned during surgery and caused the mating driver to break.The procedure was able to be completed using these two instruments without reported patient impacts.This is report two of two for this event.
 
Manufacturer Narrative
The returned handle was sent to an external laboratory for torque analysis.The torque readings were found to be in tolerance.There were no device malfunctions detected.
 
Event Description
It was reported that the torque limiting mechanism on a handle malfunctioned during surgery and caused the mating driver to break.The procedure was able to be completed using these two instruments without reported patient impacts.This is report two of two for this event.
 
Manufacturer Narrative
Udi number: (b)(4).The device was not returned so an evaluation is unable to be performed, no results are available, and no conclusions can be drawn.A review of the dhr did not find any manufacturing-related issues that would have contributed to this event.However, the handle was not returned for recalibration upon its due date in june 2017 despite requests to have it returned for calibration.
 
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Brand Name
TORQUE LIMITING T-HANDLE
Type of Device
INSTINCT JAVA SYSTEM
Manufacturer (Section D)
ZIMMER SPINE
23 parvis des chartrons
cite mondiale
bordeaux, cedex 33080
FR  33080
MDR Report Key7442954
MDR Text Key106627445
Report Number3003853072-2018-00009
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
PK111301
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 02/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number046W1AN00650
Device Lot NumberA1954005A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2018
Was the Report Sent to FDA? No
Date Manufacturer Received02/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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