• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE T2 RECON ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

  • 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
 

STRYKER TRAUMA KIEL TARGET DEVICE T2 RECON ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 1806-3100
Device Problem Failure to Align (2522)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/11/2021
Event Type  malfunction  
Event Description
It was reported the following: "one wire broke and we miss the jig three times at the very end after many attempts throughout the surgery. The broken wire intra op that we could not remove, and also, a missing attempt to pass the wire through the nail x3. " update : ((b)(6) 2021) the procedure was completed successfully. However, only one screw was placed on the femoral head, as the broken wire was on the trajectory of the second screw. The procedure was delayed by 42 minutes.
 
Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTARGET DEVICE T2 RECON
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer Contact
marilyne chaumont
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12959443
MDR Text Key281904212
Report Number0009610622-2021-00809
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K102992
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1806-3100
Device Catalogue Number18063100
Device Lot NumberKME904270
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received03/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/05/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-