TRIGEN 71691152Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556195284), received between Jul 24, 2018 and Jul 1, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2025Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING THE OSTEOSYNTHESIS PROCEDURE, THE SURESHOT HUMERAL DRILL GUIDE PROBE AND THE DONUT WERE CONNECTED AND THE EQUIPMENT RECOGNIZED THEM, EACH STEP WAS PERFORMED AND WHEN IT WAS LOOKED AT WITH THE DONUT, IT NEVER SHOWED ANYTHING AND THERE WAS NO SIGNAL. THERE WAS A SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED BY MANUALLY DRILLING THE HOLES. PATIENT WAS NOT HARMED BY THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22371849 ↗
• InjuryAug 17, 2022Imprecision; Imprecision

  IT WAS REPORTED THAT, DURING AND INTERNAL FIXATION SURGERY, THE SURESHOT HUMERAL DRILL GUIDE PROBE DID NOT CORRECTLY SHOW THE POINT FOR DISTAL BLOCKING OF THE HUMERAL ROD. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

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

  MAUDE report 15242434 ↗
• 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 11616789 ↗
• MalfunctionDec 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING SURGERY, WHILE DRILLING THE DISTAL SCREW USING A SURESHOT, IT WAS FOUND THE HOLE WAS OUT OF ALIGNMENT. THEY BELIEVE GUIDE PROBE WAS SET AT "20" BUT IT ACTUALLY WASN'T. IT WAS LOOSED. EVEN WHEN THEY TRIED TO SET "20" AGAIN, IT DID NOT WORK. DELAY FORM, (0-30) MINUTES REPORTED. BACKUP DEVICE AVAILABLE. NO INJURY OR IMPACT TO PATIENT REPORTED.

  Patient problems: No Information

  MAUDE report 9443678 ↗
• MalfunctionJul 24, 2018Application Program Problem; Application Program Problem

  IT WAS REPORTED THAT A NEW HUMERAL SURESHOT GUIDE WAS USED IN THE MIDDLE OF THE PROCEDURE, AND WHEN IT WAS CONNECTED TO THE MONITOR, IT DID NOT RECOGNIZE THE GUIDE; WE REALIZED THAT THE GUIDE WAS DAMAGED AND SPECIALIST HAD TO PERFORM THE NAIL DISTAL BLOCKS WITH FREEHAND AND THE HELP OF AN INTENSIFIER

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7713186 ↗