TRIGEN 71674540Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00885556363348), received between May 2, 2019 and Apr 20, 2026 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (9 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.

• MalfunctionApr 20, 2026Fracture

  IT WAS REPORTED THAT, DURING A FEMUR ORIF SURGERY, THE TIP OF AN INTERTAN LAG SCREW DRILL BROKE OFF IN THE FEMUR HEAD WHILE DRILLING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924146 ↗
• MalfunctionJul 7, 2022Break; Break

  IT WAS REPORTED THAT, DURING A IM NAIL PROCEDURE, THE INTERTAN LAG SCREW DRILL TIP HAD BROKEN OFF. SURGERY WAS RESUMED, WITH A LESS THAN OR EQUAL TO 30 MINUTES DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14950210 ↗
• MalfunctionJun 10, 2022Break; Break

  IT WAS REPORTED THAT A INTERTAN LAG SCREW DRILL BROKE. SINCE IT WAS NOTICED DURING AN INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14659499 ↗
• MalfunctionApr 21, 2022Crack; Crack

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE INTERTAN LAG SCREW DRILL WAS CRACKED AND THEREFORE CANNOT BE STERILIZED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14176404 ↗
• InjuryJul 14, 2021Break; Break

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, AN INTERTAN LAG SCREW DRILL BROKE WHILE INSTRUMENTS WERE INSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12166447 ↗
• MalfunctionJun 14, 2021Break; Break

  IT WAS REPORTED THAT, THE INTERTAN LAG SCREW DRILL WAS BROKEN. IT IS UNKNOWN IF THIS WAS NOTICED DURING SURGERY OR NOT; THEREFORE, PATIENT INVOLVEMENT IS NOT CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11991435 ↗
• MalfunctionApr 13, 2021Mechanical Jam; Naturally Worn; Mechanical Jam; Naturally Worn

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY IT WAS NOTICED THAT THE INTERTAN LAG SCREW DRILL IS WORN AND THE GUIDE WIRE GETS STUCK CONSISTENTLY. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11655919 ↗
• MalfunctionFeb 11, 2021Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, OUTSIDE THE PATIENT, A INTERTAN LAG SCREW DRILL BROKE AND NEEDS TO BE REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH+NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11312954 ↗
• MalfunctionFeb 11, 2021Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE BROKE OUTSIDE THE PATIENT. THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11312288 ↗
• InjuryOct 16, 2020Fluid/Blood Leak; Fluid/Blood Leak

  WHILE ATTENDING A SHORT INTERTAN NAIL FOR A NECK OF FEMUR (NOF) ON A YOUNG FEMALE WITH STRESS FRACTURE TO INFERIOR NECK, IT WAS FOUND THICKENED CORTICES FROM LONG HISTORY OF STEROID USE FOR IMMUNE DISORDER. A CANAL REAMING WAS PLANNED TO ACCOMMODATE 10MM 20CM NAIL. DURING THE PROCEDURE, A SHORT INTERTAN NAIL WAS CHOSEN, IT WAS ATTACHED TO DRILL GUIDE (DRILL GUIDE HANDLE) AND DROP (125 RAD DRILL GDE DROP) , THE NAIL WAS INTRODUCED OVER BALL TIP GUIDE WIRE. PROXIMAL ICS SCREW GUIDE PIN ADVANCED USING ACCORDING DROP, IT WAS DIFFICULT TO ADVANCE GUIDE PIN TO 25MM TIP APEX (MARKED RESISTANCE). LAG DRILL (INTERTAN LAG SCREW DRILL) ADVANCED OVER GUIDE WIRE WITH MUCH DIFFICULTY TO THE REQUIRED DEPTH (LAG SCREW WAS TAPPED TO GET TO THE REQUIRED DEPTH). BLACK SUBSTANCE NOTED IN FLUTES OF DRILL. THEN THE COMPRESSION DRILL (7.0MM COMPRESSION SCREW DRILL) MET SIMILAR RESISTANCE BUT COULD GET THE REQUIRED DEPTH. A DISTAL LOCKING WAS ATTEMPTED THROUGH THE INTERTAN DROP, IT MARKED RESISTANCE USING THE DRILL. A LATERAL X-RAY CONFIRMED SCREW WAS NOT IN THE NAIL BUT POSTERIOR TO IT, SCREW REMOVED AND NO FURTHER ATTEMPT TO DISTAL LOCK WAS UNDERTAKEN. A DELAY OF LESS THAN 30 MIN WAS REPORTED. PROCEDURE

  Patient problems: Foreign Body In Patient

  MAUDE report 10689728 ↗
• InjuryOct 21, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE SURGEON WAS PERFORMING AN INTERTAN ON A PATIENT WHO WAS ON BIPHOSPHONATES . THE BONE WAS EXTREMELY HARD AND THE GUIDE WIRES KEPT BENDING AND AS THEY HIT THE HARD BONE THEY CURVED AWAY, WHEN TRYING TO DRILL FOR THE LAG SCREW THE TIP OF THE DRILL BROKE OF WE BELIEVE THIS IS BECAUSE IT HIT THE NAIL. THEY REMOVED THIS NAIL AND REPLACED THE NAIL WITH A NEW ONE. THEY LEFT THE TIP OF THE DRILL BIT INSIDE THE PATIENT AND CARRIED ON WITH THE INTERTAN. MORE THAN 30 MINUTES DELAY WAS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9216073 ↗
• MalfunctionSep 13, 2019Break; Break

  IT WAS REPORTED THAT THE CUSTOMER ATTEMPTED TO USE THE COMBINED INTEGRATED LAG AND COMPRESSION SCREW METHOD INTO THE NECK OF FEMUR, HOWEVER ONCE THE COMPRESSION STARTER DRILL WAS USED IT APPEARED TO CATCH ON THE JIG/NAIL CAUSING SIGNIFICANT DRILL DAMAGE AND INSUFFICIENT DRILL DEPTH FOR THE COMPRESSION SCREW. AS AN ALTERNATIVE THE DECISION WAS MADE TO USE A SINGLE LAG SCREW INSTEAD WHICH AGAIN CAME INTO CONTACT WITH THE JIG/NAIL AND CAUSED SIGNIFICANT DAMAGE TO THE LAG SCREW. NO MORE INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9038252 ↗
• MalfunctionMay 2, 2019Break; Break

  IT WAS REPORTED THAT DRILL BROKE OFF WHILE DRILLING IN THE FEMORAL NECK AND THE DRILL BIT WAS RETRIEVED VIA THE GUIDE WIRE. REPLACEMENT WAS AVAILABLE. SURGERY TIME EXTENDED ABOUT 15 MINUTES. NO HARM TO PATIENT, SURGERY CONTINUED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8574257 ↗

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