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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SPINE FINAL SCREWDRIVER SHAFT; INSTINCT JAVA SYSTEM
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ZIMMER SPINE FINAL SCREWDRIVER SHAFT; INSTINCT JAVA SYSTEM Back to Search Results
Catalog Number 046W1AN00640
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/09/2018
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 report 3003853072-2018-00115.
 
Event Description
It was reported that two final screw driver shafts were broken while final tightening the blocker during surgery.An alternative final screw driver was used to complete the procedure without reported patient impacts.This is report two of two for this event.
 
Manufacturer Narrative
Udi number: (b)(4).The driver was not returned, so an evaluation was unable to be performed.Therefore, there are no results available and no conclusions can be drawn.A review of the manufacturing records did not identify any issues that would have contributed to this event.
 
Event Description
It was reported that two final screw driver shafts were broken while final tightening the blocker during surgery.An alternative final screw driver was used to complete the procedure without reported patient impacts.This is report two of two for this event.
 
Manufacturer Narrative
The returned device was examined.The tip was fractured and twisted.The complaint is confirmed.The cause is likely related to over-torquing or not being fully seated within the mating blocker during usage.
 
Event Description
It was reported that two final screw driver shafts were broken while final tightening the blocker during surgery.An alternative final screw driver was used to complete the procedure without reported patient impacts.This is report two of two for this event.
 
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Brand Name
FINAL SCREWDRIVER SHAFT
Type of Device
INSTINCT JAVA SYSTEM
Manufacturer (Section D)
ZIMMER SPINE
23 parvis des chartrons
cite mondiale
bordeaux, cedex 33080
FR  33080
MDR Report Key8146964
MDR Text Key130033492
Report Number3003853072-2018-00116
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,foreig
Type of Report Initial,Followup,Followup
Report Date 08/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number046W1AN00640
Device Lot NumberA2667303A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2019
Was the Report Sent to FDA? No
Date Manufacturer Received07/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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