• 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 LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 13X360MM 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 LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 13X360MM X 125 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 3425-3360S
Device Problem Fracture (1260)
Patient Problems Pain (1994); Injury (2348); Non-union Bone Fracture (2369); Implant Pain (4561)
Event Date 06/09/2020
Event Type  Injury  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
As reported: "on the (b)(6) 2020 the patient falls and gets a long gamma3 nail due to a subtrochanteric fracture. The patient comes to a xray control on (b)(6) because of pain. The patient did not heal, and in retrospect the surgeon can see on the x-rays, that the nail had given in on pt control (b)(6) 2020. The patient's pain got worse and the nail gave in. There were lack of healing. On the patient got a reoperation with exchange of nail, and grafting. Outcome is still uncertain. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLONG NAIL KIT R1.5, TI, RIGHT GAMMA3 13X360MM 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
GM D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer Contact
kevin smith
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10329690
MDR Text Key201039580
Report Number0009610622-2020-00371
Device Sequence Number1
Product Code HSB
UDI-Device Identifier04546540406668
UDI-Public04546540406668
Combination Product (y/n)N
PMA/PMN Number
K034002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3425-3360S
Device Catalogue Number34253360S
Device Lot NumberK07FB17
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/17/2019
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: 07/27/2020 Patient Sequence Number: 1
-
-