MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X55 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18965055S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported by the customer, "breakage of the distal screws of the femoral nail".
Additional Manufacturer Narrative
Please note correction to d9/h3.The reported event could be confirmed, since the screw is broken as reported.The device inspection revealed the following: the visual inspection has shown that the locking screw is broken apart.Both fragments of the screw were returned for evaluation.During the microscopic inspection the typical characteristics of a fatigue fracture could be identified on the fracture face.There is a fatigue zone with a smooth surface and progression lines over almost the whole surface which ends in an instantaneous zone, where the screw finally broke apart.There are impression marks at the screw thread visible, these marks indicate that the screw was exposed to high loads while it was implanted.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.No product related issue could be detected.There was no additional information about the event provided, no x-rays and no information about patient history or activity was available.Therefore the root cause of the breakage cannot be defined.The evaluation of the plate has shown that fatigue did lead to the breakage of the device.Based on the available information were the implants implanted in march 2022 and the event date was in december 2023, in this relation following statement of the the gamma3 instructions for use (l22000066 rev ab, 01-2022) can be mentioned: "the lifetime for internal fixation devices is defined by their function in the human body.Internal fixation devices for osteosynthesis are intended to keep bone fragments/segments in a correct anatomical position until reliable bone consolidation is achieved.It must be considered that these devices are developed based upon the available scientific knowledge at the time of design and manufacture.The current scientific literature on the time the fracture takes to heal, as related to the gamma3 implants or to the identified similar benchmark devices / state-of-the-art, is limited.However, the individual values reported in 18 separate data sources range from an average of 2.2 to 14.5 months (median = 3.4 months; iqr = 1.4 months) for endpoints related to time to union / healing.These devices are not intended to have a permanent function.It is known from the clinical literature that if bone consolidation is not achieved, these fracture fixation devices may fail and require removal.This risk of implant failure is dependent on numerous individual factors, including but not limited to a patient¿s pre-existing medical conditions, gender, age, body weight, bone quality, patient activity, and other variables.The interaction between implant and body ends only with the complete removal of the implant.The removal of these internal fixation devices after bone consolidation has been achieved is not mandatory.The licensed healthcare professional must always weigh the risks of an implant removal against its benefits for the individual patient." if more information is provided, the case will be reassessed.
Event or Problem Description
As reported by the customer, "breakage of the distal screws of the femoral nail".

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X55 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• 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: 18516526
• Report Number: 0009610622-2024-00033
• Device Sequence Number: 12659312
• Product Code: HSB
• UDI-Device Identifier: 04546540202529
• UDI-Public: 04546540202529
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2024

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: 04/30/2026
• Device Catalogue Number: 18965055S
• Device Lot Number: K01CCB3
• 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: 12/22/2023
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2021
• 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: 63 YR
• Patient Sex: Unknown