MAUDE Adverse Event Report: STRYKER GMBH TIBIAL NAIL, STANDARD T2 TIBIA Ø9X315 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18220931S
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "t2 tibial nail mounted incorrectly on jig and implanted incorrectly into patient.No revision surgery is planned as fracture has reduced and healing".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Nonetheless, based on the information provided, it could be determined that the reported incident was caused by incorrect assembly of the devices.Hcp most probably failed to properly follow the steps and indications from the surgical technique."t2 tibial nail mounted incorrectly on jig and implanted incorrectly into patient." however, it is not known whether this incorrect use was intentional or whether it was due to a lack of knowledge of the device.As a reminder, the instructions for use clearly state that: "the licensed healthcare professional and operating room team must be thoroughly familiar with the system.Complete information and labeling on these subjects must be readily available at the workplace.Only use an instrument for its intended purpose.Improper use of instruments might lead to loss in function or usage." 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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "t2 tibial nail mounted incorrectly on jig and implanted incorrectly into patient.No revision surgery is planned as fracture has reduced and healing.".

• Brand Name: TIBIAL NAIL, STANDARD T2 TIBIA Ø9X315 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21838671
• Report Number: 0008031020-2025-00682
• Device Sequence Number: 12787726
• Product Code: HSB
• UDI-Device Identifier: 04546540197764
• UDI-Public: (01)04546540197764(17)280531(10)K154B7A
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K003018
• 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): 06/10/2025

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: Health Professional
• Device Catalogue Number: 18220931S
• Device Lot Number: K154B7A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2023
• 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 Sex: Unknown