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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
Event Date 12/22/2017
Event Type  Injury  
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.
 
Event Description
It was reported that the tip of a driver fractured during surgery.The tip remains implanted in the blocker.An alternative driver was used to complete the procedure.There were no further patient impacts reported as a result of this event.
 
Manufacturer Narrative
The returned driver shaft was evaluated.The tip was confirmed to have fractured off in a manner consistent with screw installation.The torque limiting handle which was used in conjunction with this driver shaft was not returned for evaluation, so the root cause cannot be determined.A review of the manufacturing records did not identify any issues which would have contributed to 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 Key7193346
MDR Text Key97323650
Report Number3003853072-2018-00001
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
Report Date 05/10/2018
1 Device was Involved in the Event
Is this an Adverse Event Report? Yes
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 Manufacturer01/09/2017
Initial Date Manufacturer Received 12/22/2017
Initial Date FDA Received01/16/2018
Supplement Dates Manufacturer Received05/07/2018
Supplement Dates FDA Received05/10/2018
Is This a Reprocessed and Reused Single-Use Device? No
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