MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø13X380MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3425-3380S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "revision today that involved the removal of a gamma3 long nail which had broken approximately 3 months after initial implant.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "revision today that involved the removal of a gamma3 long nail which had broken approximately 3 months after initial implant.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the nail is broken as reported.The device inspection revealed the following: the visual inspection has shown that the nail is broken apart at the lag screw hole.The typical characteristics of a fatigue fracture could be identified on both fracture faces.There is a fatigue zone with a smooth surface and progression lines over almost the whole surface of the fracture at the fracture face on the left side.On the right side is a fatigue zone with a smooth surface and progression lines on about half of the surface, the rest of the surface is the instantaneous zone, where the nail finally broke apart.There are strong impression marks from the lag screw visible, these marks indicate that the nail was exposed to high loads.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.The complaint was forwarded to medical affairs for review with following feedback: "the initial osteosynthesis seems to be okay.We learn from the general information of the patient, that he has diabetes (potentially reduced bone repair due to lack of metabolism) and the compliance may be reduced (loss of follow up, visit in other hospitals), a very high likelihood of additional impact/trauma/mechanical forces/load on the construct due to several falls.Therefore, we have at least three patient related factors which may have led to the failure." based on investigation, the root cause was attributed to patient related factors.The nail could finally could not resist the applied force which finally led to material overload and the fatigue failure of the device.If more information is provided, the case will be reassessed.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø13X380MM 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16134157
• Report Number: 0009610622-2023-00008
• Device Sequence Number: 7636583
• Product Code: HSB
• UDI-Device Identifier: 04546540406675
• UDI-Public: 04546540406675
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2023

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: 3425-3380S
• Device Catalogue Number: 34253380S
• Device Lot Number: K07CA1F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2022
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2022
• 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 Sex: Male