Multi System P99-190-TX06Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00889795052070), received between Feb 9, 2026 and Sep 16, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Fracture” (14 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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794485 ↗
• MalfunctionSep 16, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794481 ↗
• MalfunctionSep 11, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736949 ↗
• MalfunctionJun 18, 2026Fracture

  IT WAS REPORTED THAT DURING A SCARF OSTEOTOMY FOR BUNION REPAIR, THE CANNULATED SCREWDRIVER BLADE BROKE DURING INSERTION OF A SCREW FOR METATARSAL FIXATION. DURING FIXATION, THE SURGEON DRILLED OVER A K-WIRE, MEASURED THE REQUIRED SCREW LENGTH, AND COUNTERSUNK THE BONE. UPON INITIATING SCREW INSERTION IN THE MID-SHAFT REGION OF THE METATARSAL, THE CANNULATED SCREWDRIVER BLADE FRACTURED. THERE WAS A BRIEF INTRA-OPERATIVE DELAY OF LESS THAN 30 SECONDS WHILE THE WIRE WAS REMOVED AND A SOLID TX06 SCREWDRIVER BLADE WAS PROVIDED, AFTER WHICH THE SCREW WAS SUCCESSFULLY INSERTED. 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 25550088 ↗
• MalfunctionMay 21, 2026Fracture

  IT WAS REPORTED THE TIP OF THE DRIVER BROKE OFF. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25246354 ↗
• MalfunctionMay 21, 2026Fracture

  IT WAS REPORTED THE TIP OF THE DRIVER BROKE OFF. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25246308 ↗
• MalfunctionMay 21, 2026Fracture

  IT WAS REPORTED THE TIP OF THE DRIVER BROKE OFF DURING A CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAYS. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241611 ↗
• MalfunctionApr 9, 2026Fracture

  IT WAS REPORTED THAT DURING TIGHTENING OF A 2 MM CANNULATED SCREW, THE DRIVER TIP FRACTURED AND LODGED WITHIN THE SCREW HEAD. INTRA-OPERATIVELY, THE BROKEN TIP AND ASSOCIATED DEBRIS WERE RETRIEVED FROM THE PATIENT. THERE WERE NO CLINICAL SIGNS OR SYMPTOMS AS A RESULT OF THE DRIVER BREAK. THERE WERE NO UNANTICIPATED SURGICAL COMPLICATIONS THAT OCCURRED. THERE WERE NO CONTRIBUTING CONDITIONS RELATED TO THE EVENT. THE PROCEDURE WAS NOT DELAYED AND WAS COMPLETED WITH A DIFFERENT DEVICE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24827879 ↗
• MalfunctionMar 4, 2026Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGEON WAS ATTEMPTING TO INSERTING A SCREW THE DRIVER FRACTURED. THE SURGERY WAS COMPLETED NO HARM OR DELAY TO THE PATIENT OR USER. ATTEMPTS HAVE BEEN MADE AND ALL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507407 ↗
• MalfunctionMar 4, 2026Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGEON WAS ATTEMPTING TO INSERT A SCREW; THE DRIVER FRACTURED. THE SURGERY WAS COMPLETED. NO HARM OR DELAY TO THE PATIENT OR USER. ATTEMPTS HAVE BEEN MADE AND ALL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507397 ↗
• MalfunctionFeb 23, 2026Fracture

  IT WAS REPORTED THAT TWO SCREWDRIVERS BROKE INTRA-OPERATIVELY DURING A SURGICAL PROCEDURE. THE PROCEDURE PROCEEDED WITH A 5-MINUTE DELAY. 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 24421917 ↗
• MalfunctionFeb 23, 2026Fracture

  IT WAS REPORTED THAT THE TIP OF A CANNULATED HEX DRIVER BROKE INTRA-OPERATIVELY DURING THE FINAL STAGE OF INSERTING A 2.5 MM HEADLESS SCREW. THE PROCEDURE FOLLOWED THE SURGICAL TECHNIQUE. THE BROKEN DRIVER TIP WAS RETRIEVED, AND THE CASE WAS COMPLETED WITHOUT DELAY. 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 24421453 ↗
• MalfunctionFeb 9, 2026Fracture

  IT WAS REPORTED THAT DURING A BOAT OSTEOTOMY FOR HALLUX VALGUS CORRECTION USING 2.0 HEADLESS CANNULATED SCREWS, THE DRIVER TIP BROKE WHILE THE SURGEON WAS TIGHTENING A SCREW. THE BROKEN FRAGMENT WAS REMOVED FROM THE SCREW HEAD, NO DEBRIS REMAINED IN THE PATIENT, AND A SPARE CANNULATED TIP WAS USED TO COMPLETE THE CASE. 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 24292010 ↗
• MalfunctionFeb 9, 2026Fracture

  IT WAS REPORTED THAT THE TIP OF A CANNULATED HEX DRIVER BROKE INTRA-OPERATIVELY DURING THE FINAL STAGE OF INSERTING A 2.5 MM HEADLESS SCREW. THE BROKEN TIP WAS RETRIEVED, AND THE PROCEDURE WAS COMPLETED WITHOUT DELAY. 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 24291994 ↗