MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, RIGHT GAMMA3 11X340MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3225-0340S
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Codes	Failure of Implant (1924); Hip Fracture (2349)
Date of Event	03/04/2016
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 cutout.The 22 out of 290 cases.
Event or Problem 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 gamma3 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 cutout.22 out of 290 cases.

• Brand Name: LONG NAIL KIT R2.0, TI, RIGHT GAMMA3 11X340MM X 125
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 7778703
• Report Number: 0009610622-2018-00738
• Device Sequence Number: 1793393
• Product Code: HSB
• UDI-Device Identifier: 07613153312758
• UDI-Public: 07613153312758
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 3225-0340S
• Device Catalogue Number: 32250340S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 12/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention