Monster Screw System P99-190-TT10Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889795041234), received between Mar 17, 2026 and Sep 14, 2026 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Fracture

  It was reported that a screwdriver broke intra-operatively during an ORIF ankle procedure. The procedure was completed using a secondary screwdriver available as backup, and no fragments or components fell into the patient. There were no consequences or impact to the patient. Attempts have been made and no further information has been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50752571 ↗
• MalfunctionAug 10, 2026Fracture

  It was reported the driver tip broke during surgery. The surgery was successfully completed with another driver, and all debris was removed with no report of injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50194913 ↗
• MalfunctionJul 9, 2026Fracture

  IT WAS REPORTED THAT DURING SURGERY, UPON OPENING THE INSTRUMENT SET, ONE OF THE TWO SCREWDRIVER SHAFTS WAS FOUND BROKEN. THE SECOND SCREWDRIVER SHAFT IN THE SET WAS USED, AND THERE WAS NO DELAY TO THE PROCEDURE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25769477 ↗
• MalfunctionJul 2, 2026Fracture

  IT WAS REPORTED THAT, DURING AN ANKLE OPEN REDUCTION AND INTERNAL FIXATION PROCEDURE, A DRIVER TIP FRACTURED AT THE STAR INTERFACE WHILE TIGHTENING 4.0 MM CANNULATED MEDIAL MALLEOLUS SCREWS. THE FRACTURED FRAGMENT WAS RETRIEVED, AND THE PROCEDURE WAS COMPLETED USING A REPLACEMENT TIP. DURING INTRAOPERATIVE TIGHTENING, THE SURGEON SWITCHED HANDS DUE TO FATIGUE AND THEN NOTICED INCREASED MOVEMENT OF THE DRIVER ON THE SCREW HEAD PRIOR TO THE TIP FRACTURING. THE FRAGMENT WAS REMOVED WITHOUT MAJOR DELAY, AND A DIFFERENT TIP WAS USED TO COMPLETE SCREW TIGHTENING. NO KNOWN PATIENT IMPACT OR ADVERSE CONSEQUENCE WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25690743 ↗
• MalfunctionJun 12, 2026Fracture

  IT WAS REPORTED THE DRIVER WAS FOUND CHIPPED DURING INSPECTION. NO OCCURRENCE DURING A PROCEDURE WAS REPORTED. 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 25491442 ↗
• MalfunctionMar 17, 2026Fracture

  IT WAS REPORTED THAT A SURGICAL SCREWDRIVER BROKE OFF INTRA-OPERATIVELY DURING A PROCEDURE. THE SCREWDRIVER FRACTURED DURING USE UNDER NORMAL SURGICAL TECHNIQUE OF THE RIGHT SURGICAL SIDE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT CONSEQUENCES, IMPACT, OR DELAY USING THE SAME SCREWDRIVER. ALL DEBRIS WAS REMOVED. THERE WERE NO CONTRIBUTING CONDITIONS RELATED TO THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618509 ↗