• 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 UNKNOWN GAMMA3 TROCHANTERIC NAIL IMPLANT

  • 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 UNKNOWN GAMMA3 TROCHANTERIC NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 09/29/2016
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided in a supplemental. Device not available to stryker.
 
Event Description
Stryker became aware of an article published in the ¿journal of the chinese medical association¿, ¿risk factors for cutout failure of gamma3 nails in treating unstable intertrochanteric fractures¿ published in september 29, 2016 and is associated with gamma3 trochanteric nails. An analysis of 176 patients, which was within that publication, 24 postoperative complications/ adverse events were reported, which occurred between 2010 and 2014. It was not possible to ascertain specific device or patient information from the article. A review of the complaint handling databases however revealed that the events had not been reported by the hospital or by the author of the publication, therefore 24 events were initiated retrospectively. This product inquiry addresses a cutout failure for an unknown gamma3 trochanteric nail.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN GAMMA3 TROCHANTERIC NAIL
Type of DeviceIMPLANT
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
melissa guattery
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7390077
MDR Text Key104135758
Report Number0009610622-2018-00132
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeTW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 04/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_KIE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 04/02/2018 Patient Sequence Number: 1
-
-