MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X320MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3425-1320S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
The customer informed stryker that on june 24, during the me of a gamma3 11mm 320 125-degree nail on the right, the nail broke in the is broken in the upper area.
Additional Manufacturer Narrative
The reported event could be confirmed, since the nail is broken apart as complained.The device inspection revealed the following: the visual inspection has shown that the nail broke apart at the lag screw hole.The typical characteristics of a fatigue fracture could by identified under the microscope.There are also strong deformations at the fracture face visible, which indicates that the surfaces rubbed against each other over.In addition is on one side of the lag screw hole a strong deformation with compressed material visible, this deformation was caused by the lag screw and indicates that the nail was over a long period of time exposed to a high load in this area.The relevant dimensions were verified during the investigation and no deviation from the specification could be detected.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a patient factor related issue.The breakage of the device after 22 months of implantation, is most likely to be caused due to overloading of the device over a long period of time.Presence of signs of a fatigue fracture and absence of any remarkable user induced damage to the device supports this cause.Based on the provided information did the device finally break during the material extraction, but the visible signs show that the nail was previously almost completely broken apart due to the fatigue failure.If more information is provided, the case will be reassessed.
Event or Problem Description
The customer informed stryker that on june 24, during the me of a gamma3 11mm 320 125-degree nail on the right, the nail broke in the is broken in the upper area.
Additional Manufacturer Narrative
Please note corrections to section h6 (method code and conclusion code).
Event or Problem Description
The customer informed stryker that on june 24, during the me of a gamma3 11mm 320 125-degree nail on the right, the nail broke in the is broken in the upper area.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X320MM 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
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12196441
• Report Number: 0009610622-2021-00612
• Device Sequence Number: 3397750
• Product Code: HSB
• UDI-Device Identifier: 07613252273813
• UDI-Public: 07613252273813
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/17/2021

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 Expiration Date: 05/31/2024
• Device Model Number: 3425-1320S
• Device Catalogue Number: 34251320S
• Device Lot Number: K0750A5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 09/28/2021; 10/25/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 10/20/2021; 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female