MAUDE Adverse Event Report: STRYKER GMBH T2 PHN - PROXIMAL HUMERAL NAIL LONG, LEFT D8X240 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18322824S
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
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: "after inserting the t2 proximal humeral nail, the end cap +2 failed to engage and could not be inserted.Subsequently, an attempt to insert 0mm end cap also failed to engage.Despite thorough visualization and careful preparation, insertion remained impossible.Ultimately, the procedure was completed without the end cap.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the affected device was not returned and no other evidence was shared for evaluation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More information as well as the affected device must be available in order to determine the exact contribution of the nail in the alleged issue.However, upon examining the end caps, it was found that those were deformed which most likely led to impairment in assembling.If the device is received or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "after inserting the t2 proximal humeral nail, the end cap +2 failed to engage and could not be inserted.Subsequently, an attempt to insert 0mm end cap also failed to engage.Despite thorough visualization and careful preparation, insertion remained impossible.Ultimately, the procedure was completed without the end cap.".

• Brand Name: T2 PHN - PROXIMAL HUMERAL NAIL LONG, LEFT D8X240 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23707098
• Report Number: 0008031020-2025-02119
• Device Sequence Number: 10650028
• Product Code: HSB
• UDI-Device Identifier: 04546540437099
• UDI-Public: (01)04546540437099(17)300331(10)K11F07D
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K043404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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: 18322824S
• Device Lot Number: K11F07D
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2025
• 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: 42 YR
• Patient Sex: Unknown
• Patient Weight: 100 KG