• 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 ONE SHOT TARGET DEVICE GAMMA3® 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 ONE SHOT TARGET DEVICE GAMMA3® ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 13203010
Device Problems Failure to Align (2522); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/30/2019
Event Type  malfunction  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
It was reported that when the one shot device was used it was noticed that the lines one x-ray indicating lag screw position did not align with the hole in the nail. Looking along the length of the one shot device it was noted that there was a twist along its length. Procedure was completed successfully with no surgical delay or adverse consequences reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameONE SHOT TARGET DEVICE GAMMA3®
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8922764
MDR Text Key161691951
Report Number0009610622-2019-00623
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K123401
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 11/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number13203010
Device Lot NumberKME906237
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-