• 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, STST GAMMA3 11X180MM X 120 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, STST GAMMA3 11X180MM X 120 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 41201180S
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); Pain (1994); Injury (2348); Implant Pain (4561)
Event Date 02/13/2020
Event Type  Injury  
Manufacturer Narrative
The reported device is not cleared for sale in the us, however a similar device is cleared for sale in the us. Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
A pharmacist, reported that: "a nail gamma stryker was placed the (b)(6) 2018 and removed the (b)(6) 2020 after 4 months of pain. The initial fracture that justified the nail was consolidated. The radiography before the nail's removal showed a suspicion of fracture of the material, confirmed by the expelled material: rupture at the level of the cervical screw. The patient did not fall.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTROCHANTERIC NAIL KIT, STST GAMMA3 11X180MM X 120
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
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9844972
MDR Text Key193098908
Report Number0009610622-2020-00111
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K043431
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 09/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number41201180S
Device Lot NumberKU84874
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/17/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/17/2020 Patient Sequence Number: 1
-
-