MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL GT, LEFT T2 ALPHA FEMUR ANTEGRADE Ø10X380MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2331-1038S
Medical Device Problem Codes	Break (1069); Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	02/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "a priorly implanted t2 alpha antegrade nail was explanted.A gamma nail was used as a replacement.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.Device disposition unknown.
Additional Manufacturer Narrative
Please note corrections to b1, h6 device code and h6 clinical code.The reported event could be confirmed, since the received nail is broken apart as complained.The received x-ray was also reviewed and the breakage in the area of the lag screws can be confirmed.The device inspection revealed the following: the visual inspection has shown that the nail broke apart at the second lag screw hole.On top and on the bottom of the bore where the fracture occurred are strong impression marks visible, caused by high loads between the nail and the lag screw.The fracture face was inspected under the microscope and the typical characteristics of a fatigue fracture could by identified.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 nail was returned for evaluation and no product related issue could be detected.More detailed information about the event must be available, the provided x-ray is just in one plane and no pre-operative and post-operative x-rays were provided, also was no patient data provided and it is unknown how long the device was implanted, therefore the root cause of this event cannot be defined.The evaluation of the nail has shown that fatigue did lead to the breakage of the device, the implant could not resist the applied force which finally led to a material overload / fatigue failure.In this relation following statement from the instructions for use can be mentioned: "these devices can break when subjected to the increased loading associated with delayed unions and/or non-unions.Internal fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing.If healing is delayed or does not occur, the appliance may eventually break due to metal fatigue.Loads on the device produced by load bearing and the patient¿s activity level will dictate the longevity of the device." if updated information is provided, the case will be reassessed.
Event or Problem Description
As reported: "a priorly implanted t2 alpha antegrade nail was explanted.A gamma nail was used as a replacement." additionally, information received during the investigation showed that the original nail needed to be revised as it broke.This was noticed in x-rays.

• Brand Name: FEMORAL NAIL GT, LEFT T2 ALPHA FEMUR ANTEGRADE Ø10X380MM
• 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: 13839222
• Report Number: 0009610622-2022-00098
• Device Sequence Number: 16474429
• Product Code: HSB
• UDI-Device Identifier: 07613327289589
• UDI-Public: 07613327289589
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2022

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: 2331-1038S
• Device Catalogue Number: 23311038S
• Device Lot Number: K08225ARA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 03/21/2022
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2020
• 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: Unknown