MAUDE Adverse Event Report: STRYKER GMBH T2 HUMERUS - HUMERAL NAIL D7X280 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18300728S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
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: "breaking of the locking pins on a diaphyseal humeral nail." additional feedback received: "how was the event detected? during surgery, when it became impossible to continue the procedure.When inserting the humeral nail, the nail was placed on the nail holder, the screw was tightened correctly, and the nail anchor was checked.The anvil was positioned to impact the nail.A rotational movement was performed to align the nail and position it correctly.During the rotation, a crack was heard, with abnormal mobility between the nail holder and the nail.Did the event occur during the procedure? if yes: was the procedure completed correctly? yes, during the procedure, it was completed correctly.Was there any impact on the patient? / any clinical consequences for the patient? no impact on the patient.Was the procedure delayed? if yes: by how much time (in minutes)? the procedure was delayed by 25-30 minutes while we fetched an ancillary device to extract the nail and reposition another one.Was additional medical intervention necessary? no.".
Event or Problem Description
As reported: "breaking of the locking pins on a diaphyseal humeral nail." additional feedback received: "how was the event detected? during surgery, when it became impossible to continue the procedure.When inserting the humeral nail, the nail was placed on the nail holder, the screw was tightened correctly, and the nail anchor was checked.The anvil was positioned to impact the nail.A rotational movement was performed to align the nail and position it correctly.During the rotation, a crack was heard, with abnormal mobility between the nail holder and the nail.Did the event occur during the procedure? if yes: was the procedure completed correctly? yes, during the procedure, it was completed correctly.Was there any impact on the patient? / any clinical consequences for the patient? no impact on the patient.Was the procedure delayed? if yes: by how much time (in minutes)? the procedure was delayed by 25-30 minutes while we fetched an ancillary device to extract the nail and reposition another one.Was additional medical intervention necessary? no." 02/17/2026 - additional information received: the nail has a fastening system on the nail holder consisting of small studs, one of which is broken and the other damaged.The breakage occurred when the nail was inserted.
Additional Manufacturer Narrative
Correction: please refer to section d9 the device was not returned.The reported event could not be confirmed during the investigation.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.Note: the reported breakage is not visible on the photos received.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.

• Brand Name: T2 HUMERUS - HUMERAL NAIL D7X280 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 GMBH; 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: 24300092
• Report Number: 0008031020-2026-00142
• Device Sequence Number: 9332305
• Product Code: HSB
• UDI-Device Identifier: 04546540201348
• UDI-Public: (01)04546540201348(17)300731(10)K13C95B
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K032523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2026

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: 18300728S
• Device Lot Number: K13C95B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 03/03/2026; 06/02/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/31/2026; 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2025
• 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 Sex: Unknown