TRIGEN 71674035Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 03596010560551), received between Oct 31, 2017 and Jul 2, 2025 — classified as 6 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, THE COMPRESSION SCREW HEXDRIVER BROKE DURING SURGERY. 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 22391662 ↗
• MalfunctionFeb 18, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF A COMPRESSION SCREW HEXDRIVER BROKE. 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 21403710 ↗
• MalfunctionDec 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING TRAUMA SURGERY, NOTICED THAT THE TIP OF THE COMPRESSION SCREW HEXDRIVER WAS BROKEN OFF. MADE IT MORE DIFFICULT TO ENGAGE COMPRESSION SCREW. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819469 ↗
• MalfunctionJan 15, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERTAN PROCEDURE, THE END OF ONE (1) COMPRESSION SCREW HEXDRIVER CAME OFF. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT, BECAUSE THE DRIVER WAS OVER A GUIDE WIRE. 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 18510593 ↗
• InjuryNov 21, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE END OF THE COMPRESSION SCREW HEXDRIVER BROKE AND REMAINED IN THE END OF THE SCREW, WHEN INSERTING THE COMPRESSION SCREW. SURGERY WAS FINISHED AFTER A NON-SIGNIFICANT DELAY, AND CHANGING THE SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15839760 ↗
• MalfunctionJun 9, 2022Break; Break

  IT WAS REPORTED THAT, THE COMPRESSION SCREW HEXDRIVER RETAINING ROD WAS BROKEN. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14640532 ↗
• MalfunctionJun 8, 2022Break; Break

  IT WAS REPORTED THAT, THE COMPRESSION SCREW HEXDRIVER RETAINING ROD WAS BROKEN. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14640248 ↗
• MalfunctionMay 31, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE COMPRESSION SCREW HEXDRIVER WAS FOUND CORRODED. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14548528 ↗
• InjuryMay 20, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A COMPRESSION SCREW HEXDRIVER BROKE AT THE TIP WHEN INSERTING THE SCREW. THE BROKEN PIECE WAS REMOVED WITH TWEEZERS. SURGERY WAS FINISHED, AFTER A NON-SIGNIFICANT DELAY, USING A BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14454793 ↗
• MalfunctionMar 24, 2022Material Twisted/Bent; Material Split, Cut or Torn; Material Twisted/Bent; Material Split, Cut or Torn

  IT WAS REPORTED THAT A COMPRESSION SCREW HEXDRIVER WAS SPLIT AND BENT. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13878733 ↗
• MalfunctionDec 21, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE THREADS OF THE COMPRESSION SCREW HEXDRIVER WERE SEEN TO BE DAMAGED. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13052005 ↗
• MalfunctionDec 20, 2021Crack; Crack

  IT WAS REPORTED THAT THE TIP OF A COMPRESSION SCREW HEXDRIVER WAS CHIPPED. NO MORE DETAILS ARE KNOWN AT THIS MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13043584 ↗
• MalfunctionSep 29, 2021Break; Break

  IT WAS REPORTED THAT A TRIGEN COMPRESSION SCREW HEXDRIVER IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12551046 ↗
• MalfunctionSep 20, 2021Break; Break

  IT WAS REPORTED THAT, DURING SCREW EXCHANGE SURGERY, THE TIP OF A TRIGEN COMPRESSION SCREW HEXDRIVER BROKE OFF AND STAYED ATTACHED TO THE CAPTURE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12494376 ↗
• MalfunctionJun 2, 2021Corroded; Corroded

  IT WAS REPORTED THAT DURING SPD, IT WAS NOTICED THAT THE COMPRESSION SCREW HEXDRIVER HAD SEVERE OXIDATION/RUST INSIDE. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11918382 ↗
• MalfunctionMay 21, 2021Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT, DURING A TRAUMA PROCEDURE, IT WAS NOTICED THAT THE FOLLOWING INSTRUMENTS OF THE TRIGEN¿ INTERTAN¿ INSTRUMENT SET ARE WARPED DUE TO WEAR AND TEAR OVER PAST 3 YEARS: LAG SCREW DRILL SLEEVE ((B)(4)), INTERTAN 3.2MM GUIDE PIN SLEEVE ((B)(4)), LAG SCREW TAP ((B)(4)), LAG SCREW DRIVER ((B)(4)), COMPRESSION SCREW HEXDRIVER ((B)(4)), SUBTROC LAG SCREW DRIVER ((B)(4)), 130 RAD DRILL GDE DROP ((B)(4)), UNKNOWN TRIGEN INSTRUMENT ((B)(4)), UNKNOWN TRIGEN INSTRUMENT ((B)(4)). THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS GREATER THAN 30MINS DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11861865 ↗
• MalfunctionMay 20, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE COMPRESSION SCREW HEXDRIVER STRIPPED. THERE WAS NO 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 11853491 ↗
• MalfunctionMay 19, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE COMPRESSION SCREW HEXDRIVER WAS WARPED AND NOT FUNCTIONING PROPERLY. THERE WAS NO 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 11852130 ↗
• MalfunctionMay 5, 2021Connection Problem; Material Deformation; Connection Problem; Material Deformation

  IT WAS REPORTED THAT, AFTER A TRAUMA SURGERY, AT THE END OF THE COMPRESSION SCREW HEXDRIVER WAS DEFORMED AND DID NOT ACCEPT A MINI T. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11780693 ↗
• MalfunctionMay 5, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE SLOTTED END OF A COMPRESSION SCREW HEXDRIVER´S INNER SLEEVE IS CLOSED. NO CASE WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11780689 ↗
• MalfunctionMay 4, 2021Break; Break

  IT WAS REPORTED THAT AFTER SURGERY THE COMPRESSION SCREW HEXDRIVER TIP SNAPPED OFF RENDERING IT USELESS. AS THIS WAS NOTICED AFTER SURGERY, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773119 ↗
• MalfunctionApr 21, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT AFTER AN INTERNAL FIXATION SURGERY, THE DRIVER OF A COMPRESSION SCREW HEXDRIVER WAS NOT FITTING ONTO SCREWS DUE TO IT BEING BENT. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE WITHOUT ANY DELAYS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704294 ↗
• MalfunctionApr 21, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION PROCEDURE, WHILE INSIDE THE PATIENT, THE END OF THE COMPRESSION SCREW CAPTURE APPEARED TO BE PINCHED TO THE POINT WHERE IT WAS DIFFICULT TO CAPTURE THE SCREW ONCE INSERTED. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704291 ↗
• MalfunctionApr 6, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING INSPECTION PROCESS, THE TIP OF THE COMPRESSION SCREW HEXDRIVER WAS NOTICED TO BE BENT, AND DID NOT PROPERLY FIT THE SCREW HEAD. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624903 ↗
• MalfunctionApr 5, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, THE COMPRESSION SCREW HEXDRIVER WAS BENT AND NEEDS TO BE REPLACED. INCIDENT OCCURRED AFTER THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11612173 ↗