TRIGEN 71631444Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00885556158333), received between Oct 22, 2020 and Mar 25, 2024 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 16, 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.

• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED THAT, DURING A META-TAN PROCEDURE, THE RETENTION ROD OF ONE (1) META-TAN COMP SCREW DRIVER BROKE WHILE TRYING TO PLACE ON THE SCREW. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18975672 ↗
• MalfunctionJan 30, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION PROCEDURE, A META-TAN COMP SCREW DRIVER BROKE. IT IS UNKNOWN HOW PROCEDURE WAS COMPLETED OR IF A DELAY OCCURRED DUE TO THIS EVENT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607772 ↗
• MalfunctionJun 7, 2022Break; Break

  IT WAS REPORTED THAT A META-TAN SCREW DRIVER HAS A BROKEN TIP. THE CONTEXT IN WHICH THIS OBSERVATION WAS MADE IS UNSPECIFIED. THEREFORE, PATIENT INVOLVEMENT IS YET TO BE CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14611751 ↗
• MalfunctionJun 6, 2022Break; Break

  IT WAS REPORTED THAT THE TIP OF THE META-TAN COMP SCREW DRIVER BROKE. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14611081 ↗
• MalfunctionApr 25, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT, A META-TAN COMP SCREW DRIVER IS STRIPPED. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14192413 ↗
• MalfunctionJan 19, 2022Break; Break

  IT WAS REPORTED THAT DURING A THR, THE META-TAN COMP SCREW DRIVER BROKE OFF INTO THE HEX DRIVER. THE DEVICE BROKE OUTSIDE THE PATIENT. THERE WAS A DELAY OF 30 MINUTES OR LESS AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13292496 ↗
• MalfunctionJan 11, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A META-TAN COMP SCREW DRIVER BROKE IN TWO. SURGERY WAS COMPLETED, WITH THE SAME DEVICE, WITHOUT ANY DELAY. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13226067 ↗
• InjuryJan 11, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, PART OF THE META-TAN COMP SCREW DRIVER BROKE UP WHILE INSERTION. A SMALL PIECE TIP OF THE DEVICE ENTER TO THE PATIENT. SURGERY WAS RESUMED WITHOUT ANY DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. PATIENT WAS NOT HARMED. THE PATIENT CURRENT HEALTH STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13225531 ↗
• InjuryJan 11, 2022Break; Break

  IT WAS REPORTED THAT DURING TRAUMA SURGERY, THE END OF THE META-TAN COMP SCREW DRIVER BROKE OFF UPON ADVANCING THE COMPRESSION SCREW INTO THE PATIENT. NO INJURY TO PATIENT REPORTED. FURTHER INFORMATION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13225289 ↗
• MalfunctionJan 10, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A META-TAN COMP SCREW DRIVER BROKE IN TWO OUTSIDE THE PATIENT. SURGERY WAS COMPLETED, WITH THE SAME DEVICE, WITHOUT ANY DELAY. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13210271 ↗
• InjuryMar 3, 2021Break; Break

  IT WAS REPORTED THAT WHILE HAND TIGHTENING THE COMPRESSION SCREW, THE TIP OF THE COMPRESSION SCREW DRIVER BROKE OFF IN THE COMPRESSION SCREW WHILE DOING A META-TAN SURGERY. THIS HAPPENED DURING FINAL TIGHTENING. IT WAS ABLE TO RETRIEVE THE BROKEN OFF HEX HEAD FROM THE INSERTED COMPRESSION SCREW. THIS FAILURE CAUSED NO ADVERSE ACTION OR TIME DELAY WITH CASE. THERE WAS A SMITH AND NEPHEW BACK UP DEVICE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11407499 ↗
• MalfunctionNov 2, 2020Break; Break

  IT WAS REPORTED THAT THE SCREWDRIVER WAS FOUND BROKEN WHEN OPENED. THIS WAS FOUND DURING SET UP / INSPECTION. NO SURGERY OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10774314 ↗
• MalfunctionOct 22, 2020Break; Break

  IT WAS REPORTED THAT, ON INSPECTION, IT WAS NOTICED THAT THE HEX END WAS BROKEN. NO CASE OR PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10722147 ↗

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