• 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 TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 125 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 TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 125 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 31251180S
Device Problem Difficult or Delayed Separation (4044)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/09/2020
Event Type  malfunction  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
Customer reported to sales rep that: "we have a nail gamma stuck on the nail holder. " sales rep reported that: "yesterday [surgeon] placed a short gamma nail on a patient, and when he wanted to remove the nail holder from the nail, he couldn't unscrew it. He opened another ancillary to put another nail in. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 125
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
D-24232
Manufacturer Contact
kevin smith
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10033569
MDR Text Key191466472
Report Number0009610622-2020-00188
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K034002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 08/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number31251180S
Device Lot NumberK037C66
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-