TRIGEN 71692814Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010648143), received between May 15, 2018 and May 21, 2022 — classified as 3 injuries, 6 malfunctions.

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

• MalfunctionMay 21, 2022Delivered as Unsterile Product; Material Deformation; Packaging Problem; Delivered as Unsterile Product; Material Deformation; Packaging Problem

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION PROCEDURE, THE SURESHOT META STANDARD DRILL GUIDE PROBE STERILE PACKAGING WAS NOTED TO BE PARTICULARLY CRUMPLED. THE DEVICE WAS UNWRAPPED AND NOTED TO HAVE A SLIGHTLY ODD S SHAPE BEND TOWARDS THE DISTAL END. 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. NO FURTHER COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14467034 ↗
• MalfunctionMay 6, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED, THE SURESHOT META STANDARD DRILL GUIDE PROBE STERILE PACKAGE WAS PARTIALLY OPEN WHICH COMPROMISED THE PRODUCT'S STERILITY. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14311448 ↗
• MalfunctionSep 21, 2020Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING AN OSTEOSYNTHESIS OF THE FEMUR WITH A RETROGRADE NAIL, AT THE TIME OF PERFORMING NAVIGATED DISTAL LOCKS, THE MONITOR DID NOT RECOGNIZE THE SENSOR OF THE SURESHOT GUIDE, FOR WHICH THE MONITOR WAS TURNED OFF. A NEW ATTEMPT WAS MADE AND IT IS NOT POSSIBLE, AN ALERT APPEARED ON THE MONITOR, "INVALID OR BROKEN SENSOR", THE PROCEDURE COULD BE COMPLETED WITHOUT THE USE OF THIS GUIDE. NO DAMAGE CAUSED. PATIENT'S CONDITIONS IS STABLE. DELAY LESS THAN OR EQUAL OF 30 MINUTES. PROCEDURE FINISHED WITH S&N BACKUP DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10564687 ↗
• MalfunctionAug 15, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE SYSTEM COULD NOT RECOGNIZE THE PROBE DURING THE SURGERY, DELIVERING AN ERROR MESSAGE. A DELAY OF 0 TO 30 MINUTES REPORTED. NO PATIENT INJURIES REPORTED. AN S&N BACKUP WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10411792 ↗
• InjuryMay 21, 2020Inadequate User Interface; Inadequate User Interface

  IT WAS REPORTED THAT THE WRONG TYPE OF PROBE WAS ORDERED BY SALES REP'S MISUNDERSTANDING FOR TRIGEN META-TAN SURGERY. DURING OPERATION, THE NAIL AND THE PROBE WAS INSERTED AND THEN THE PROBE WAS CONNECTED TO SURESHOT SYSTEM. THE MONITOR DISPLAYED ONLY TIBIAL NAIL, SO THE MISTAKE WAS FOUND. USING RADIOLUCENT DRILL, THE SURGERY WAS COMPLETED. NO HARM TO PATIENT, 15 MINUTES DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10080862 ↗
• MalfunctionDec 30, 2019Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT DURING SURGERY AND AFTER OPENING THE PACKAGE THE NAVIGATION COULDN'T DETECT THE NEWLY DRILL GUIDE PROBE. THE DISTAL SCREWS WERE INSERTED BY FREE HAND WHICH IS CONSIDERED A DIFFERENT TECHNIQUE, THERE WAS A DELAY FROM 30 TO 60 MINUTES WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9532667 ↗
• MalfunctionApr 3, 2019Application Program Problem; Application Program Problem

  IT WAS REPORTED THAT DURING SURGERY, WARNING MESSAGE SUGGESTED METAL INTERFERENCE HAD BEEN DISPLAYED. THERE WAS NO METAL OBJECT WITHIN 20 CM FIELD. USING RADIOLUCENT DRILL, THE OPERATION WAS CONTINUED. NO IMPACT OR HARM TO PATIENT. 15 MINUTES DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8479052 ↗
• InjuryMar 7, 2019Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING DRILLING THE MOST DISTAL SCREW HOLE (THE FIRST HOLE FROM THE DISTAL END OF THE NAIL), AN ERROR MESSAGE WAS DISPLAYED AND DISAPPEARED CONTINUOUSLY. THEN DESPITE TARGETING THE HOLE ON THE SCREEN, DRILLING THE HOLE WAS NOT SUCCESSFUL (IT WAS DRILLED OUT OF SCREW HOLE). AN RLD WAS USED TO DRILL TWO HOLES (THE FIRST AND THIRD HOLE FROM THE DISTAL END OF THE NAIL) AND COMPLETE THE PROCEDURE. THE SURGERY WAS DELAYED FOR 15 MINUTES.

  Patient problems: Injury

  MAUDE report 8401410 ↗
• InjuryMay 15, 2018Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A TRAUMA SURGERY, THE META-NAIL TIBIAL WAS USED WITH SURESHOT AND INSERTION OF THE PROBE ATTEMPTED AFTER PROXIMAL LOCKING. AFTER THE PROBE WOULD NOT PROGRESS WITH FORCE, THE ISSUE WAS IDENTIFIED AND PROXIMAL SCREWS RETRACTED. DISTAL LOCKING WAS DONE USING SURESHOT AND WORKED AS EXPECTED BUT WHEN REMOVING THE PROBE, THE DISTAL END REMAINED WITHIN THE NAIL IN THE PATIENT AND MAY COME IN CONTACT WITH BODY FLUIDS GIVEN THAT NOT ALL HOLES HAVE BEEN FILLED.

  Patient problems: Injury

  MAUDE report 7513460 ↗