Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SPINE FINAL SCREWDRIVER SHAFT II; INSTINCT JAVA SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 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 2 of 4 for this event.
 
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 2 of 4 for this event.
 
Manufacturer Narrative
E1: establishment name: (b)(6) medical university.This follow-up report is being submitted to relay additional information and initially corrected information.Added information to d4: unique identifier (udi) number, d8, h6: component codes, type of investigation, investigation findings, investigation conclusions corrected information in d9, e1: establishment name, h3.Summary: the complaint is also confirmed for the returned instinct java drivers (pn 046w1an00641) for the failure of fracturing while attempting to remove a blocker.Medical records were not provided for review.Device evaluation: the item numbers and lot numbers of all five devices match information listed in the complaint fie.The two drivers are confirmed to have fractured tips and are unusable.Potential cause the overtightening could have lead to the force required to remove the blocker being higher than the force that the material of the blocker and drivers could handle, thus damaging the driver.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10503283
MDR Text Key206000075
Report Number3003853072-2020-00100
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 Number046W1AN00641
Device Lot NumberA2701901A
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
-
-