Vitality® 07.02054.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00889024009806), received between Nov 23, 2021 and Nov 14, 2025 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT TWO VITALITY STANDARD REDUCTION SCREWDRIVERS WOULD NOT LOAD A SCREW PROPERLY. ANOTHER DRIVER WAS USED AND THERE WAS NO PATIENT IMPACT. UPON MANUFACTURER INVESTIGATION, IT WAS DISCOVERED THAT ONE OF THE SCREWDRIVERS WAS DEFORMED AND FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556935 ↗
• MalfunctionSep 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF VITALITY SCREW DRIVER BROKE OFF IN A SCREW INTRA-OPERATIVELY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23033600 ↗
• MalfunctionMay 7, 2025Material Twisted/Bent; Material Twisted/Bent

  A DISTRIBUTOR REPORTED THAT A VITALITY DRIVER WAS FOUND TO HAVE A TWISTED TIP DURING SPD. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21979302 ↗
• InjuryMar 13, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGERY, THE TIP OF A FINAL VITAL DRIVER FRACTURED. THIS RESULTED IN A 20 MINUTE DELAY AND THEY WERE UNABLE TO RETRIEVE THE FRACTURED TIP. THE SURGERY WAS COMPLETED USING OTHER INSTRUMENTS AND THERE WAS NO PATIENT IMPACT BEYOND THE TIP RETENTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 21595482 ↗
• MalfunctionAug 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT A VITALITY SCREWDRIVER TIP WAS DISCOVERED TO BE FRACTURED WHEN IT WAS RETURNED TO A WAREHOUSE. IT IS UNKNOWN WHEN THE DAMAGE OCCURRED, BUT THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939257 ↗
• MalfunctionJun 12, 2024Fracture; Fracture

  IT WAS REPORTED THE BLUE PLASTIC STOP INSIDE A DRIVER IS BROKEN INTO 2 PIECES PREVENTING THE SLEEVE FROM SLIDING ALL THE WAY DOWN TO ENGAGE WITH THE TULIP OF THE SCREW. IT WAS FOUND DURING A ROUTINE INSPECTION SO THE PATIENT AND SURGICAL INFORMATION IS UNKNOWN. DEVICE INSPECTION BY THE MANUFACTURER FOUND THAT THE TIP OF THE DRIVER IS DEFORMED.

  Patient problems: Insufficient Information

  MAUDE report 19518814 ↗
• MalfunctionJan 25, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGERY, THREE VITALITY DRIVERS FRACTURED WHEN TRYING TO REMOVE A STUCK ILIAC SCREW. THE SCREW WAS ULTIMATELY ABLE TO BE REMOVED AND REPLACED WITH A SHORTER SCREW. THIS RESULTED IN A 20 MINUTE DELAY TO THE PROCEDURE BUT NO OTHER PATIENT IMPACT. THIS IS REPORT TWO OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18584899 ↗
• MalfunctionMar 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TIP OF A VITALITY SCREWDRIVER WAS DIFFICULT TO CONNECT TO A MATING SCREW WHEN PUTTING THE KIT BACK TOGETHER AFTER SURGERY. THERE WERE NO IMPACTS DURING THE SURGERY. HOWEVER, DEVICE EVALUATION BY THE MANUFACTURER FOUND THE TIP WAS DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16592344 ↗
• MalfunctionFeb 13, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT TWO VITALITY CONNECTORS BROKE, THE TIP OF ONE VITALITY T20 FINAL DRIVER BROKE, THE TIP OF A VITALITY T27 DRIVER TWISTED, AND THE TIPS OF TWO VITAL NAVIGATION T27 DRIVERS TWISTED INTRA-OPERATIVELY. OTHER CONNECTORS AND DRIVERS WERE USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY TO THE PROCEDURE THAT DID NOT LEAD TO PATIENT IMPACTS. THIS IS REPORT THREE OF SIX FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16362869 ↗
• MalfunctionOct 7, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF A VITALITY SCREWDRIVER WAS FOUND FRACTURED WHEN PUTTING THE KIT BACK TOGETHER AFTER SURGERY. THERE WERE NO IMPACTS DURING THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15568141 ↗
• MalfunctionNov 29, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THE TIPS OF TWO SCREW DRIVERS WERE FOUND TO BE STRIPPED DURING A ROUTINE INSPECTION. NO PATIENT OR SURGICAL INFORMATION IN AVAILABLE. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 12888408 ↗
• MalfunctionNov 29, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THE TIPS OF TWO SCREW DRIVERS WERE FOUND TO BE STRIPPED DURING A ROUTINE INSPECTION. NO PATIENT OR SURGICAL INFORMATION IN AVAILABLE. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 12888394 ↗
• MalfunctionNov 23, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THE TIP OF THE SCREWDRIVER WAS FOUND TO BE DEFORMED AFTER SURGERY. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12864694 ↗