TRIGEN 71692802Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010648174), received between Jun 19, 2020 and May 21, 2025 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2025Imprecision; Imprecision

  IT WAS REPORTED THAT DURING TRAUMA SURGERY, THE TRAUMA INTERFACE GAVE PROBLEMS. THE MONITOR WAS NOT READING APPROPRIATELY THE RED AND GREEN CIRCLES FOR SCREW PLACEMENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETE AND IF THERE WAS ANY PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22062026 ↗
• MalfunctionDec 30, 2024Inadequate User Interface; Inadequate User Interface

  IT WAS REPORTED THAT, DURING SET UP FOR SURGERY, A TRAUMA INTERFACE WAS NOT UP TO DATE AND, WHILE RECOGNISING TAN/FAN PROBE, WOULD NOT ALLOW SELECTION OF METATAN NAIL. VERSION NUMBER WAS V3.0.0. LAUNCHER NUMBER V1.1.1 / AS A RESULT OF THE SYSTEM ERROR, THE SURGEON WAS UNABLE TO CORRECTLY DRILL ONE OF THE HOLES INTO THE PATIENT. AS A RESULT OF MISALIGNMENT, A HOLE WAS DRILLED SLIGHTLY OFF-TARGET RENDERING THE SCREW HOLE USELESS. A NEW BONE HOLE WAS DRILLED AND THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH ANOTHER SURGEON WHO WAS ABLE TO DISTALLY LOCK THE IMPLANT SUCCESSFULLY WITH THE ¿PERFECT CIRCLE¿ TECHNIQUE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: Perforation

  MAUDE report 21036260 ↗
• InjuryDec 10, 2023Output Problem; Output Problem

  IT WAS REPORTED THAT DURING A FEMUR & TIBIA INTERNAL FIXATION LOCKING IS DONE FOR THE RETROGRADE NAIL AND IT IS WELL POSITIONED. HOWEVER, THE TRAUMA INTERFACE DID NOT DISPLAY THE MEASUREMENT SIGN FOR THE LOCKING PIN. MONITOR POINTERS WERE NOT STATIC, SO ANYTHING THAT COULD BE GENERATING INTERFERENCE WAS REMOVED AND THE SIGNAL IMPROVED. THEN, WHEN PLACING THE TIBIA NAIL AND PERFORMING THE LOCKING, CALIBRATION WAS PERFORMED BY SENDING THE GUIDE TO FULL, RESULTING IN 36 OF LENGTH. AFTER THIS, IT IS REPOSITIONED TO THE LENGTH OF THE ONE SELECTED (320MM) AND THE CHANNEL IS DRILLED, AGAIN THE CONSOLE DID NOT MEASURE THE AXIAL CHANNEL TO VERIFY THE LENGTH OF THE LOCK. HOWEVER, FROM THE CONTROL PANEL OF THE CONSOLE, BEFORE REMOVING THE DRILL BIT, THE DRILLING RESULTS WERE VERIFIED AND NO ERROR IN THE MEASUREMENT FIELD WERE FOUND. THIS WAS A 29.8 MM MEASUREMENT. NONETHELESS, THIS WAS MEASURED WITH A CONVENTIONAL METER AND THE TRAUMA INTERFACE ADVANCED TO VERIFY THE LOCKING, RESULTING IN 35/2 ALMOST REACHING THE 34 LINE, THE LENGTH OF THE BOLT WAS VERIFIED WITH A MEASUREMENT ALSO VERIFIED WITH A THIS GOT VERIFIED WITH THE AND THE LENGTH OF THE BOLT IS VERIFIED WITH A METER. FOR THE SECOND LO

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18298519 ↗
• MalfunctionNov 12, 2022Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, THE SCREEN OF THE TRAUMA INTERFACE DEVICE FROZE 5 TIMES WHILE PERFORMING THE DISTAL LOCKING. NO DRILL HOLES WERE PERFORMED AS THE SCREEN KEPT FREEZING. TROUBLESHOOTING WAS UNSUCCESSFUL. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY WITH A CHANGE IN THE SURGICAL TECHNIQUE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15785832 ↗
• InjuryApr 19, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING META-TIBIA NAIL APPLICATION WITH SURESHOT PROCEDURE, SURESHOT INTERFACE WAS TURNED ON AND DISPLAYED ERROR: CRC CHECK FIELD. NO PATIENT INJURY, NO DELAY, CHANGE IN SURGICAL TECHNIQUE WERE USED TO FINISH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11689784 ↗
• InjuryApr 5, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY A HO LOAN KIT WAS USED AND SEVERAL INCONVENIENT WERE NOTICED. THE SURESHOT HUMERAL DRILL GUIDE PROBE FAILED. THE PROXIMAL JIG WAS FAULTY CAUSING ALL OF THE PROXIMAL SCREWS TO MISS THE NAIL. ALL SCREWS ENDED UP BEING DONE BY HAND MAKING PERFECT CIRCLES WITH BOTH DISTAL SCREWS AND PROXIMAL SCREWS. IT WAS REPORTED A SIGNIFICANT THE CASE ENDED UP DELAYED FOR OVER 2 HOURS. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11616784 ↗
• InjuryJan 10, 2021Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT, DURING SURGERY, AFTER TURNING ON THE TRAUMA INTERFACE, IT DID NOT DISPLAY THE MAIN MENU; IT DISPLAYED WINDOWS SCREEN. SEVERAL ATTEMPTS OF TURNING OFF/ON THE SYSTEM, THE ISSUE WAS NOT RESOLVED. USING A RADIOLUCENT DRILL, THE OPERATION WAS COMPLETED. 4 MIN SURGICAL DELAY. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11144565 ↗
• InjuryJul 13, 2020Computer Software Problem; Application Program Problem; Computer Software Problem; Application Program Problem

  IT WAS REPORTED THAT,DURING SURGERY, WHILE CONNECTING SURESHOT TARGETER TO TRAUMA INTERFACE, AN ERROR MESSAGE WAS DISPLAYED. THOUGH SEVERAL ATTEMPTS OF TURNING OFF/ON THE SYSTEM, THE ERROR WAS DISPLAYED. BY USING FREE HAND TECHNIQUE, THE SURGERY WAS COMPLETED. NO HARM TO PATIENT. SURGERY TIME EXTENDED 10 MINUTES. THE DEVICE WILL BE RETURNED FOR EVALUATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

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

  MAUDE report 10268307 ↗
• InjuryJun 19, 2020Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT, DURING A TIBIAL NAIL SURGERY, SURESHOT MONITOR (TRAUMA INTERFACE) COULDN'T BE TURNED ON AND FREE HANDS WERE USED TO COMPLETE THE SURGERY. CURRENT STATE OF HEALTH OF THE PATIENT IS GOOD. THERE ARE NO OPERATIVE REPORTS AVAILABLE.

  Patient problems: Injury

  MAUDE report 10174574 ↗