T15 Hexalobe Drive 201.047.15Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00851599007655), received between Mar 11, 2024 and Dec 30, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2025Material Twisted/Bent; Insufficient Device Problem Information; Material Twisted/Bent; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING RESTOCK WITHIN THE STERILIZATION DEPARTMENT AT THE HOSPITAL, THE DEVICE LOOKED MALFUNCTIONED AND POSSIBLY WARPED. THERE WAS NO PATIENT INVOLVEMENT. HOWEVER, ONCE PRODUCT WAS RETURNED IT WAS NOTED THAT THE TIP WAS TWISTED AND CRACKED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23923431 ↗
• MalfunctionNov 14, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A DRIVER WAS WORN BUT WAS DISCOVERED TO BE FRACTURED POST INVESTIGATION. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554292 ↗
• MalfunctionMar 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE BLADE FRACTURED WITH THE TIP BEING FRACTURED OFF. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633038 ↗
• MalfunctionMar 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE BLADE FRACTURED WITH THE TIP BEING FRACTURED OFF. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633028 ↗
• InjuryMar 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A CABG PROCEDURE, A TORQUE LIMITER WAS NOT PLACED ON THE DRILL AND THE TIP OF THE SCREW BLADE BROKE OFF AND WAS LATER DISCOVERED TO BE LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED AS PLANNED AND IT WAS NOT NOTED UNTIL DAYS LATER THAT THE BLADE HAD FRACTURED. THERE WAS NO MEDICAL INTERVENTION AND IT WAS DEEMED THAT THE RISK OF REMOVING THE BROKEN PIECE WAS A HIGHER RISK THAN TO LEAVE IT INSIDE THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18878122 ↗