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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 Calibration Problem (2890)
Patient Problem No Code Available (3191)
Event Date 08/19/2020
Event Type  malfunction  
Manufacturer Narrative
Udi#: (b)(4).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 3003853072-2020-00099 to 3003853072-2020-00102.
 
Event Description
It was reported that during surgery, the surgeon was reviewing the c-arm image and decided he needed to adjust the angle of the screw.When he attempted to remove the screw, the tips of two final drivers broke, the broken tips were retrieved the blocker stripped in the tulip head and the screw could not be pulled out.It was reported that the torsion force of t-handle is too large, which leads to the fracture of screwdriver.There was an approximate 20 minute delay and competitor product was used to complete the case.There were no reported patient impacts.This is report 1 of 4 for this event.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information and initially corrected information.Summary: the complaint is confirmed for the returned instinct java torque limiting t-handle (pn 046w1an00650) for the failure of over-torquing.Medical records were not provided for review.Device evaluation: visual inspection of the t handle reveals surface level scratches along the metal of the device.Torque testing of the device gave results at 135 inch pounds, 160 inch pounds, and 185 inch pounds.Varied results and the high of 185 inch pounds confirm that the device is not functional.Potential cause: root cause was unable to be determined.The torque limiting driver (tld) could have gone out of calibration due to lack of calibration by the customer, or due to internal damage caused prior to or during the surgery.Dhr review and related actions: per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.A follow-up report will be submitted if new information is received that changes the information provided in this report.Reference reports 3003853072-2020-00099 to 3003853072-2020-00102.
 
Event Description
It was reported that during surgery, the surgeon was reviewing the c-arm image and decided he needed to adjust the angle of the screw.When he attempted to remove the screw, the tips of two final drivers broke, the broken tips were retrieved the blocker stripped in the tulip head and the screw could not be pulled out.It was reported that the torsion force of t-handle is too large, which leads to the fracture of screwdriver.There was an approximate 20 minute delay and competitor product was used to complete the case.There were no reported patient impacts.This is report 1 of 4 for this event.
 
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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 Key10503271
MDR Text Key206000113
Report Number3003853072-2020-00099
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 03/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number046W1AN00650
Device Lot NumberA200673405
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2020
Was the Report Sent to FDA? No
Date Manufacturer Received02/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age57 YR
Patient Weight66
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