• 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 Consequences Or Impact To Patient (2199)
Event Date 09/07/2020
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.Not returned to manufacturer.
 
Event Description
It was reported that the tip of the instinct java final screwdriver fractured during the operation.The tip was retrieved and the procedure was completed with an alternate final screwdriver.There were no reported patient impacts.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
Cmp (b)(6).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, d11, g3, g4, g7, h1, h2, h3, h6, h10.D4: udi #(b)(4).G3: foreign china.The complaint is confirmed for one (1) of one (1) returned instinct java final screwdriver shaft ii (pn 046w1an00641) for the failure of fractured tip.The dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimmer biomet¿s control.No medical records were provided with the complaint.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
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 Key10642043
MDR Text Key210223030
Report Number3003853072-2020-00103
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
Report Date 11/03/2020
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 NumberA2649802A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/08/2020
Initial Date FDA Received10/07/2020
Supplement Dates Manufacturer Received11/02/2020
Supplement Dates FDA Received11/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Age55 YR
Patient Weight80
-
-