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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 05/16/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6).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 reports 3003853072-2018-00041 through 3003853072-2018-00045.
 
Event Description
It was reported that a torque limiting handle did not limit the torque applied to four blockers during surgery, and the threads on all four blockers were damaged.The procedure was completed using alternative blockers.There were no reports of patient impacts associated with this event.This is report one of five for this event.
 
Manufacturer Narrative
Udi number: (b)(4).The returned handle was evaluated.Torque testing by an external laboratory found the torque met specifications.There were no devices problem detected.A review of the manufacturing records did not identify any issues which would have contributed to this event.
 
Event Description
It was reported that a torque limiting handle did not limit the torque applied to four blockers during surgery, and the threads on all four blockers were damaged.The procedure was completed using alternative blockers.There were no reports of patient impacts associated with this event.This is report one of five for this event.
 
Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
 
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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 Key7609387
MDR Text Key111475138
Report Number3003853072-2018-00041
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 12/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number046W1AN00650
Device Lot NumberA236820602
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2018
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/21/2018
Initial Date FDA Received06/18/2018
Supplement Dates Manufacturer Received09/24/2018
12/17/2018
Supplement Dates FDA Received10/17/2018
12/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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