T2 1830-0728SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540201348), received between Dec 2, 2019 and Feb 9, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Break; Fracture

  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 W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24300092 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, DELAYED UNION WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

  Patient problems: Impaired Healing

  MAUDE report 19956447 ↗
• MalfunctionJul 30, 2020Break; Fracture; Break; Fracture

  PHARMACIST REPORTED THAT: "THE OPERATING BLOCK PLACED THIS MORNING A HUMERAL NAIL T2, REF#: (B)(4). DURING INSTALLATION THE NAIL ((B)(4) ¿ LOT K295422RA) BROKE ON THE EXTREMITY."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10347443 ↗
• MalfunctionDec 2, 2019Break; Material Fragmentation; Break; Material Fragmentation

  IT HAS BEEN REPORTED BY THE CUSTOMER THAT THE NAIL WAS BROKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9398269 ↗