TRIGEN 71674570Recalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 00885556389393), received between Oct 31, 2017 and Jun 1, 2026 — classified as 28 injuries, 67 malfunctions.

The most frequently reported specific device problem is “Break” (48 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 95 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Fracture

  IT WAS REPORTED THAT, DURING A FEMORAL NAIL SURGERY, THE TIP OF ONE (1) INTERTAN 7.0MM COMP SCREW STARTER DRILL SNAPPED OFF DURING USE AND COULD NOT BE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25354048 ↗
• MalfunctionMay 31, 2026Break

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE TIP OF AN INTERTAN 7.0MM COMP SCREW STARTER DRILL BROKE. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACK-UP. HOWEVER, IT IS UNKNOWN IF THIS CAUSES ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25342849 ↗
• MalfunctionFeb 25, 2026Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE TIP OF A INTERTAN 7.0MM COMP SCREW STARTER DRILL BROKE OFF. ALL PIECES WERE RECOVERED, BUT IT IS UNKNOWN IF ANY FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24441793 ↗
• MalfunctionFeb 10, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTERTAN SURGERY, THE TIP OF THE INTERTAN 7.0MM COMP SCREW STARTER DRILL BROKE INSIDE PATIENT, AS THE DEVICE WAS BEING USED TO DRILL THE LATERAL CORTEX. THE BROKEN INSTRUMENT PIECE REMAINED IN THE PATIENT; IT WAS IDENTIFIED AND RETRIEVED DURING THE SAME SURGICAL PROCEDURE WITHOUT PROLONGED RETENTION. THE FRAGMENT WAS COMPLETELY RETRIEVED USING STANDARD SURGICAL INSTRUMENTS UNDER DIRECT VISUALIZATION. NO ADDITIONAL INJURY TO THE PATIENT OCCURRED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24310166 ↗
• MalfunctionNov 13, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TRAUMA SURGERY, AN INTERTAN 7.0MM COMP SCREW STARTER DRILL TIP BROKE OFF. ALL BROKEN PIECES WERE RETRIEVED AND ACCOUNTED FOR USING A DEVICE SIMILAR TO TWEEZERS. THE PATIENT LEFT SURGERY IN GOOD HEALTH. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY USING AN EQUIVALENT S+N BACK UP. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23542495 ↗
• MalfunctionAug 13, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF ONE (1) INTERTAN 7.0MM COMP SCREW STARTER DRILL BROKE OFF DUE TO A CABLE. ALL BROKEN PIECES WERE ACCOUNTED FOR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22801146 ↗
• MalfunctionJun 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY THE TIP OF ONE (1) INTERTAN 7.0MM COMP SCREW STARTER DRILL SNAPPED OFF WHILE DRILLING INTO THE PATIENT. THE BROKEN PIECES WERE REMOVED WITH TWEEZERS. THE PROCEDURE WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22155447 ↗
• MalfunctionMay 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION, THE TIP OF ONE (1) INTERTAN 7.0MM COMP SCREW STARTER DRILL BROKE. ALL THE BROKEN PIECES WERE RETRIEVED; NOTHING WAS LEFT IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960427 ↗
• MalfunctionApr 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE TIP OF ONE (1) INTERTAN 7.0MM COMP SCREW STARTER DRILL BROKE OFF WHILE DRILLING IN THE LATERAL CORTEX. THE SURGEON REMOVED IT FROM THE LATERAL CORTEX WITH A NEEDLE DRIVER. IT WAS CONFIRMED THAT ALL METAL MATERIAL WAS REMOVED WITH X-RAY. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928020 ↗
• MalfunctionMar 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A NAIL FIXATION, WHEN THE INTERTAN 7.0MM COMP SCREW STARTER DRILL WAS BEING USED, THE TIP BROKE OFF RENDERING IT NO LONGER FIT FOR PURPOSE. IT IS UNKNOWN HOW WAS COMPLETED THE PROCEDURE. NO DELAY OR INJURY TO PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21692833 ↗
• MalfunctionMar 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) INTERTAN 7.0MM COMP SCREW STARTER DRILL HAD BROKEN MIDSHAFT IN NORMAL USE EXTERNAL TO PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21572475 ↗
• MalfunctionFeb 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION PROCEDURE, AN INTERTAN 7.0MM COMP SCREW STARTER DRILL BROKE AS SURGEON STARTED TO DRILL AND ON CONTACT WITH THE BONE; NOT INSIDE THE BONE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293140 ↗
• MalfunctionJan 23, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF ONE [1] INTERTAN 7.0MM COMP SCREW STARTER DRILL BROKE WHILE USING. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED AND NO DELAY WAS REPORTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21217107 ↗
• MalfunctionDec 19, 2024Break; Break

  IT WAS REPORTED THAT, DURING A FIXATION SURGERY, ONE (1) INTERTAN 7.0MM COMP SCREW STARTER DRILL'S TIP BROKE WHILE IN USE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE AVAILABLE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20984547 ↗
• MalfunctionDec 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING INTERTAN SURGERY, THE DISTAL TIP OF ONE (1) INTERTAN 7.0MM COMP SCREW STARTER DRILL BROKE. SURGEON HAD TO TAKE OUT THE IM NAIL TO RETRIEVE THE DISTAL TIP FROM THE NAIL AND REINSERT THE INTERTAN NAIL. THE BROKEN PIECE WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY OF ABOUT 10 MINUTES, WITH A S+N BACK-UP DEVICE (STARTER DRILL FROM METATAN NAIL SET). NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20861125 ↗
• MalfunctionNov 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, THE END OF ONE (1) INTERTAN 7.0MM COMP SCREW STARTER DRILL SNAPPED OFF WHILE BEING USED ON PATIENT. THE BROKEN PIECE WAS RETRIEVED WITH TWEEZERS BY THE SURGEON. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622033 ↗
• MalfunctionNov 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, BOTH THE TIPS OF A T7 LINEAR DRIVER SHAFT W/ AO QC AND A INTERTAN 7.0MM COMP SCREW STARTER DRILL BROKE OFF. ALL PIECES WERE FOUND AND REMOVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20606286 ↗
• MalfunctionOct 29, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE SURGEON WAS PREPPING FOR LAST COMPRESSION SCREW, AND WHEN HE USED THE INTERTAN 7.0MM COMP SCREW STARTER DRILL HE WAS ABLE TO ADVANCE IT PARTIALLY UNTIL THE TIP OF THE DRILL BROKE OFF. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20556219 ↗
• MalfunctionSep 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING NAIL PROCEDURE, AN INTERTAN 7.0MM COMP SCREW STARTER DRILL BROKE. NO PIECES FELL INTO PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20286768 ↗
• MalfunctionSep 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AND INTERNAL FIXATION SURGERY, THE TIP OF A INTERTAN 7.0MM COMP SCREW STARTER DRILL BROKE INSIDE THE PATIENT. THE PIECE WAS RETRIEVE USING TWEEZERS. THERE WAS A NON- SIGNIFICANT DELAY 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 20118257 ↗
• MalfunctionAug 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERTAN NAIL PROCEDURE, THE INTERTAN 7.0MM COMP SCREW STARTER DRILL WAS NOTICED WITH THE TIP BROKE OFF. THE BROKEN PIECE WAS RETRIEVED. A SMITH AND NEPHEW BACKUP DEVICE WAS AVAILABLE AND NO DELAYS WERE REPORTED. THE PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19927079 ↗
• MalfunctionJul 23, 2024Break; Break

  IT WAS REPORTED THAT DURING SURGERY, ONE (1) OF THE INTERTAN 7.0MM COMP SCREW STARTER DRILL BROKE. ADDITIONAL, THE REST OF THE DRILLS (FIVE) WERE FOUND WEAR AND TEAR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19812477 ↗
• MalfunctionMar 13, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION PROCEDURE, ONE (1) INTERTAN 7.0MM COMP SCREW STARTER DRILL BROKE DURING THE FIRST CORTEX DRILLING. THE SURGEON WAS ABLE TO REMOVE THE TIP FROM THE PATIENT USING A LONG ARTERY FORCEPS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18896166 ↗
• MalfunctionFeb 20, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION PROCEDURE, WHEN DRILLING USING ONE (1) INTERTAN 7.0MM COMP SCREW STARTER DRILL, A DRILL BIT BROKE OFF IN THE BONE. AFTER 30 MIN THE PIECE WAS ABLE TO BE RETRIEVED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18737969 ↗
• InjuryFeb 13, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A INTERTAN NAIL PROCEDURE ON LEFT SIDE, WHEN DRILLING FOR COMPRESSION AND LAG SCREWS IN THE FEMORAL HEAD, THE INTERTAN 7.0MM COMP SCREW STARTER DRILL BROKE AND THE TOP 3-5 MM END OF THE STARTER COMPRESSION DRILL WAS STUCK IN THE COMPRESSION SCREW HOLE OF SHORT NAIL. THE DRILL END OF THE DRILL WAS LEFT IN-SITU AND A LAG SCREW ONLY WAS USED IN THE FEMORAL HEAD. NO COMPRESSION SCREW WAS ABLE TO BE USED. THE LAG COMPRESSION SCREW SIZE WAS CHANGED TO ACCOMMODATE FOR THE INABILITY TO NOW ACHIEVE COMPRESSION OF THE FRACTURE IN THE FEMORAL HEAD. A SIZE UP WAS USED (95/90) AND THE FIRST LAG/COMPRESSION SCREW SIZE (90/85) WAS DISCARDED. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Foreign Body In Patient

  MAUDE report 18694825 ↗

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