MAUDE Adverse Event Report: STRYKER GMBH T2 - END CAP D10 MM, +2 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18320002S
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 be confirmed, since the returned device matches the alleged failure.The device inspection revealed the following: the received end cap showed signs of usage evident by presence of scratch marks on top.The threads of the end cap were completely deformed and flattened.The nature of deformation indicates towards cross threading during insertion, potentially due to misalignment.The returned end cap was attempted to be assembled with a sample nail because of the deformation, the end cap couldn't be inserted completely.Hence the alleged issue is confirmed.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.Based on the above investigation, the issue is deemed to be user related.The deformation in the threads of the end cap indicates towards potential misalignment during insertion, which led to resistance during insertion because of cross threading.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 - END CAP D10 MM, +2 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: 23708494
• Report Number: 0008031020-2025-02120
• Device Sequence Number: 10649602
• Product Code: HSB
• UDI-Device Identifier: 04546540379740
• UDI-Public: (01)04546540379740(17)290531(10)K1BA68C
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032523
• 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: 18320002S
• Device Lot Number: K1BA68C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2025
• 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): Yes
• Date Device Manufactured: 06/14/2024
• 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