SURFIX® 219127NDRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10381780052227), received between Jun 4, 2022 and May 12, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 12, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING REMOVAL SURGERY OF A HALLU-LOCK PLATE, A SCREWDRIVER TORX T7 BROKE OFF. NO PIECE FELL INTO THE PATIENT. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, BUT IT IS UNKNOWN HOW. NO OTHER INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924656 ↗
• MalfunctionJul 25, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE HEAD OF AN SCREWDRIVER TORX T7 WAS MISSING. THE INSTRUMENT CANNOT BE USED ANYMORE BECAUSE IT DOES NOT FIT SECURELY INTO THE HEAD OF THE SCREWS. AS THIS WAS NOTICED AFTER SURGERY, AND IT WAS CONFIRMED THAT THE BREAKAGE DID NOT OCCUR WHILE IN USE, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15093863 ↗
• MalfunctionJun 7, 2022Break; Break

  IT WAS REPORTED THAT IN SURGERY THE HALLULOCK SCREWDRIVER BROKE DURING REMOVAL OF HALLULOCK PLATE AND SCREWS. NO FURTHER INFORMATION WAS AVAILABLE. IT IS UNKNOWN THE STATUS OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14629152 ↗
• MalfunctionJun 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING THE SET UP FOR A MTP-1 ARTHRODESIS SURGERY, IT WAS NOTICED THAT A PART OF THE TIP OF A SCREWDRIVER TORX T7 WAS MISSING. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14599416 ↗
• MalfunctionJun 4, 2022Break; Break

  IT WAS REPORTED THAT, DURING STERILIZATION PROCESS AFTER SURGERY, IT WAS NOTICED THAT A PART OF THE TIP OF THE SCREWDRIVER TORX T7 HAD BROKE. PROCEDURE BEEN COMPLETED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14599415 ↗