MAUDE Adverse Event Report: STRYKER GMBH FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø12X360MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23331236S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "revision of a t2 alpha femoral nail on (b)(6) 2024 after nail fracture on 24/02/2024.".
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: "revision of a t2 alpha femoral nail on (b)(6) 2024 after nail fracture on (b)(6) 2024.".
Additional Manufacturer Narrative
Correction: please refer to section the device was returned and evaluated.The reported event could be confirmed based on the inspection performed.The device inspection revealed the following: the identification of the returned nail was confirmed based on the catalog # and the lot # marked.The nail is broken in two parts, at the level of the distal lag screw hole, both parts were returned.The evaluation revealed that the nail broke in a fatigue fracture, as confirmed by the presence of striations on one side of the broken surface.The period of implantation was not communicated.According to the damage observed, the fracture had its origination in the lateral side of the hole.Shiny areas on the broken surface are most probably a result of friction between the nail parts during a sudden fraction that led to the nail breakage.This sudden fracture was a direct result of the fatigue fracture aforementioned.Material wear and deformation on the medial edge of the proximal hole was most likely caused by increased axial loading during the implantation period; which is considered as patient behavior related.Severe damage can be observed on the edge of the distal lag screw hole.This indicates that the nail was subjected to severe loads, leading to displacement of the lag screw and the breakage of the nail.This statement is confirmed by the wear marks observed on the returned lag screw.No major wear or deformation was observed on the other holes of the nail.It must be noted that the inspection of the nail did not indicate any possible hcp related issue (such as misaligned drilling).Based on the information provided, the patient is overweight (woman, 100 kg, 160 cm).This could be a major factor explaining the nail fracture.As a reminder, overweight highly increases the risk of implant failure.As stated by the instructions for use: "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 break and will 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." however, since no x-ray was provided, the influence of patient overweight in this case could not be confirmed.X-rays would have been necessary for a complete investigation of the reported event in order to accurately determine the root cause of the nail breakage.Despite three request attempts, the images were not provided.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.If more information is provided, the case will be reassessed.

• Brand Name: FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø12X360MM
• 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: 19029241
• Report Number: 0009610622-2024-00124
• Device Sequence Number: 7068710
• Product Code: HSB
• UDI-Device Identifier: 07613327286212
• UDI-Public: 07613327286212
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

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: 02/29/2024
• Device Catalogue Number: 23331236S
• Device Lot Number: K0C4124
• 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: Not provided
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2019
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 100 KG