MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 31251180S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Non-union Bone Fracture (2369)

Event Date 01/18/2009

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device disposition is unknown.

Event Description

The manufacturer became aware of adverse events from the norwegian hip fracture register.The title of this report is ¿gamma 3 in the norwegian hip fracture register¿ which is associated with the gamma 3 locking nail system, within that report, post-operative complications/ adverse events were reported, which occurred between 1-jan-2005 and 31-dec-2016.A review of the complaint handling database revealed that the events have not been reported previously to stryker, therefore 290 complaints were initiated for the revision surgeries retrospectively for different adverse events mentioned in the report.This product inquiry addresses revision surgery due to malunion.Re-osteosynthesis was performed.The 258 out of 290 cases.It was also indicated that patient died within 60 days of revision surgery however the cause and date of death will not be disclosed.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°
• Type of Device: ROD, 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7781021
• MDR Text Key: 117124791
• Report Number: 0009610622-2018-01004
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540375070
• UDI-Public: 04546540375070
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 31251180S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention