TRIGEN 71692852Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556584644), received between Jul 24, 2020 and May 15, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Imprecision” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2025Imprecision; Imprecision

  IT WAS REPORTED THAT DURING TRAUMA SURGERY, THE TRAUMA INTERFACE GAVE PROBLEMS ON FRIDAY IN A CASE. THE MONITOR WAS READING THAT THE RED AND GREEN CIRCLES WERE CONCENTRIC IN THE MIDDLE OF THE DISTAL SCREW HOLE, HOWEVER WHEN IT WAS TRIED TO DRILL THROUGH SAID SCREW HOLE IT WAS HIT THE NAIL DESPITE THE MONITOR SHOWING THAT THE DRILL WAS IN THE RIGHT SPOT. THE PROCEDURE WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY (ABOUT 25-30 MINUTES) MAKING AN ADDITIONAL BONE HOLE, BECAUSE THE ORIGINAL HOLE WE DRILLED WAS TOO ANTERIOR. . NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation

  MAUDE report 22025054 ↗
• MalfunctionMar 25, 2024Imprecision; Imprecision

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, WHILE PERFORMING THE DISTAL BLOCKS USING A TRAUMA INTERFACE - 2ND GENERATION, THE SURESHOT FAILED TO PROVIDE THE CORRESPONDING MEASUREMENT AND COLLIDED WITH THE NAIL. THE SURGEON COMPLETED THE PROCEDURE MANUALLY AFTER A NON-SIGNIFICANT DELAY. NO INJURIES WERE REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18969655 ↗
• MalfunctionSep 1, 2021Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT, A TRAUMA INTERFACE - 2ND GEN DISPLAYED AN OXC000014C ERROR CODE . AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12408660 ↗
• InjuryMay 18, 2021Failure to Calibrate; Sparking; Failure to Calibrate; Sparking

  IT WAS REPORTED THAT, DURING HUMERAL INTERNAL FIXATION SURGERY, THE TRAUMA INTERFACE - 2ND GEN - SURESHOT WAS NOT CALIBRATING PROPERLY ON HUMERAL NAIL. DUE TO THIS EVENT, A SURGICAL DELAY GREATER THAN 30 MINUTES WAS REPORTED AND AN ALTERNATIVE SURGICAL TECHNIQUE KNOWN AS PERFECT CIRCLES WAS APPLIED TO CONCLUDE THE PROCEDURE . NO PATIENT INJURY WAS REPORTED. WHEN THE DEVICE WAS BROUGHT BACK TO OFFICE AND CALIBRATION TESTS WERE RUN, THE DEVICE SPARKED FROM THE BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11842487 ↗
• MalfunctionSep 9, 2020Failure to Power Up; Application Program Problem; Failure to Power Up; Application Program Problem

  IT WAS REPORTED THAT THE TRAUMA INTERFACE WON'T TURN ON. IT IS UNKNOWN WHETHER THE INCIDENT HAPPENED OR NOT IN A SURGICAL ENVIRONMENT OR IF THERE WAS ANY PATIENT INVOLVED. 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 10511791 ↗
• MalfunctionJul 24, 2020Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT SURESHOT HAD A SOFTWARE FAILURE. IT WAS REPORTED THAT SURESHOT HAD A SOFTWARE FAILURE. THE FAILURE WAS FOUND UPON INSPECTION. NO CASE INVOLVED.

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

  MAUDE report 10319253 ↗