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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SPINE FINAL SCREWDRIVER SHAFT II; INSTINCT JAVA SYSTEM
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ZIMMER SPINE FINAL SCREWDRIVER SHAFT II; INSTINCT JAVA SYSTEM Back to Search Results
Catalog Number 046W1AN00641
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/23/2019
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 reports 3003853072-2019-00166 to 3003853072-2019-00175.
 
Event Description
It was reported that during the procedure the threads of eight plugs were damaged, the torque handle was out of specification, and the tip of the driver fractured.The tip was removed and the case was completed using an alternate driver and closure tops.There were no patient impacts reported.This is report two of ten for this event.
 
Manufacturer Narrative
The returned device was evaluated.Visual inspection found that the tip of the driver had fractured in a manner consistent with off-axis forces.The complaint is confirmed.A review of the manufacturing records did not identify any issues related to this failure which would have contributed with this event.As this failure is regularly occurring with known causes and impacts, a summary investigation was completed.The likely cause for fracture is due to over-torquing or forces applied off axis.
 
Event Description
It was reported that during the procedure the threads of eight plugs were damaged, the torque handle was out of specification, and the tip of the driver fractured.The tip was removed and the case was completed using an alternate driver and closure tops.There were no patient impacts reported.This is report two of ten for this event.
 
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Brand Name
FINAL SCREWDRIVER SHAFT II
Type of Device
INSTINCT JAVA SYSTEM
Manufacturer (Section D)
ZIMMER SPINE
23 parvis des chartrons
cite mondiale
bordeaux, cedex 33080
FR  33080
MDR Report Key9510655
MDR Text Key182794362
Report Number3003853072-2019-00167
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K111301
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 06/24/2020
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 Number046W1AN00641
Device Lot NumberA2447214A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/25/2019
Initial Date FDA Received12/23/2019
Supplement Dates Manufacturer Received06/17/2020
Supplement Dates FDA Received06/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age66 YR
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