LARGE CANNULATED SCREWS 110120Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010033970), received between Nov 19, 2018 and May 18, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K122170); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2021Break; Break

  IT WAS REPORTED THAT DURING SET UP, THE CANN SCREWDRIVER 6.5 BROKE. IT'S UNKNOWN HOW THE PROCEDURE WAS FINISHED, BUT IT WAS PERFORMED WITHOUT ANY DELAY. PATIENT WAS NOT IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11842393 ↗
• MalfunctionNov 13, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, PLACING A 6, 5 MM CANNULATED SCREW, THE SURGEON NOTICED THAT THE BLACK HANDLE WAS NOT FIXED TO THE SCREWDRIVER SHAFT ¿ THE SCREWDRIVER WAS NOT ROTATED WHEN THE HANDLE WAS ROTATED. THEY COULD NOT PROCEED THE SURGERY AS PLANNED. THEY HAD A BACKUP 3, 5 HEX SCREWDRIVER THAT WAS NOT CANNULATED. DRILLED OVER THE PIN, TOOK OUT THE PIN AND PLACED THE CANNULATED 6, 5 MM SCREW WITHOUT THE GUIDEPIN. THERE WAS A DELAY BETWEEN 0-30 MIN DURING SURGERY. NO PATIENT INJURY OR DEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9318696 ↗
• InjuryJul 15, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE SCREW DRIVER IN THE SET WAS BROKEN (THE TIP HEX PART WAS NOT THERE) .THERE WAS NO CANNULATED DRILL BIT IN THE SET. THESE ARE TWO ESSENTIAL INSTRUMENTS FOR THE INSERTION OF THESE SCREWS, THE TAP WAS USED TO BREAK THE CORTEX, THE SCREW WAS TURNED IN BY HAND HALF WAY, WHERE THE GUIDE PIN HAD TO BE REMOVED AND THEN INSERTED ALL THE WAY. STRUCTURE WAS ALSO BOOKED WEBOPS 186773 BUT MIXING THESE WAS DIFFICULT AND DID NOT WORK WELL EVEN THOU INSTRUCTIONS WAS FOLLOWED. THE SURGEON HAD TO REVERT TO OPEN SURGERY AS HE NEEDED TO INSERT THE BONE GRAFT (THE PATIENTS WAS COUNSELED FOR ARTHROSCOPIC SURGERY AS WELL AS CONSENTED, NOT OPEN). INCREASED RISK OF INFECTION DUE TO BONE GRAFT BEING INSERTED BY HAND. LESS THAN 30 MINUTES DELAY WAS REPORTED. THE PATIENT IS NOW SEPTIC AND HAD TO BE TAKEN BACK TO SURGERY FOR A DEBRIDEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 8791757 ↗
• MalfunctionNov 19, 2018No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT A DELAY GREATER THAT 30 MINUTES OCCURED DUE TO WORN OUT SCREWDRIVER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8084474 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122170. One submission often covers many models, so check the product and lot details in each record.

• Z-0351-2020 · Oct 7, 2019 · Terminated
  LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted sha