MAUDE Adverse Event Report: STRYKER GMBH TIBIAL NAIL T2 ALPHA TIBIA Ø11X300MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23411130S
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
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: "als is gradually loosening up after surgery of t2 alpha".It was also identified that a second screw had loosened and the nail had slightly moved.
Additional Manufacturer Narrative
The reported event could be confirmed based on the x-ray image[s] provided, only.A physical inspection was impossible since the item was not made available for inspection [implanted].Provided x-ray images were forwarded to r&d for review ¿ his comments - excerpts: ¿here are my thoughts about the tibia case: there are no obvious signs of healing, so probably not a lot of time between both images.The more proximal of both distal screws has moved medially about 5mm relative to the bone.The most distal screw seems to have moved a tiny bit as well, but less.The tip of the tibia nail seems to have moved laterally a couple of mm towards lateral in respect to the bone.Both als screws had full large diameter thread contact in the initial position¿ known from a former case it could not be excluded that the primary reported loosened screw is linked to a damaged thread during implantation or a worn thread due to postoperative stress.However, based on details available a more specific statement, in particular for the nail, could not be made and more detailed information about the complaint event as well as the affected device must be available in order to determine the exact root cause of the complaint event.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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
As reported: "als is gradually loosening up after surgery of t2 alpha".It was also identified that a second screw had loosened and the nail had slightly moved.

• Brand Name: TIBIAL NAIL T2 ALPHA TIBIA Ø11X300MM
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21903089
• Report Number: 0008031020-2025-00755
• Device Sequence Number: 12967136
• Product Code: HSB
• UDI-Device Identifier: 07613327290844
• UDI-Public: (01)07613327290844(17)330331(10)K1277C6
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 23411130S
• Device Lot Number: K1277C6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/28/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2023
• 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
• Patient Age: 64 YR
• Patient Sex: Male