TRIGEN 71692801Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 03596010648167), received between Jun 2, 2020 and May 15, 2025 — classified as 31 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT, DURING THE PROCEDURE USING A SURESHOT TARGETER, THE DONUT WAS CONNECTED TO THE MONITOR AND A RED MESSAGE APPEARED SAYING: "SURESHOT ADDRESSER - TOOL INVALID OR BROKEN. REPLACE IT". THE MONITOR WAS THEN TURNED OFF AND ON, THE DONUT WAS DISCONNECTED, AND THEN RECONNECTED, BUT THE SAME RED MESSAGE CONTINUED TO APPEAR. THE SURGERY WAS COMPLETED, AFTER A SIGNIFICANT DELAY, CHANGING THE SURGICAL TECHNIQUE, AS A SHORT 4.0 DRILL BIT WAS USED AND DISTAL LOCKING WAS PERFORMED FREEHAND. A 4.0 DRILL BIT WAS INSERTED, AND SEVERAL X-RAYS WERE TAKEN TO VIEW THE NAIL HOLE AND ALLOW THE DRILL BIT TO BE INSERTED. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22023891 ↗
• InjurySep 8, 2024Material Twisted/Bent; Material Split, Cut or Torn; Material Twisted/Bent; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A HUMERAL INTERNAL FIXATION, THE CABLE OF THE SURESHOT TARGETER DEVICE WAS NOTICED TO BE IN POOR CONDITION AND HAD CRACKS. AFTER CONNECTING TO THE CONSOLE, A WARNING OF INTERFERENCE APPEARED IN THE FIELD. WHEN STARTING THE SURGERY, THE STERILITY WAS VERIFIED. HOWEVER, LATER ON, THE CABLE DAMAGE WAS NOTICED TO BE DAMAGED, WITH CRACKS AND EXPOSED SECTIONS. IN ADDITION, WHEN CONNECTING, THE DISTAL SECTION OF THE CABLE WAS NOTICED TO BE BENT AND DAMAGED, MAKING THE CONNECTION SO DIFFICULT THAT THE SUPPORT GOT CONTAMINATED IN ORDER TO ACHIEVE THE CONNECTION, WHICH INCREASED THE INFECTION RISK. ONCE THE CONNECTION WAS MADE, THE INTERFERENCE MESSAGE APPEARED. CLAMPS WERE REMOVED, ELECTRODES WERE TURNED OFF, AND THE TABLE WAS UNPLUGGED TO AVOID SAID INTERFERENCE BUT IT WAS UNSUCCESSFUL. THEREFORE, BLOCKAGES WITH THE SYSTEM WERE NOT POSSIBLE TO PERFORM. DUE TO THIS, THE SURGERY WAS PERFORMED AFTER A SIGNIFICANT DELAY, USING MANUAL TECHNIQUE TO DO THE BLOCKAGES THIS COMPLICATION GENERATED MORE ANESTHESIA TIME AND, DUE TO THE INTERFERENCE, CAUSED MORE X-RAY EXPOSURE AND MORE PERFORATIONS.". NO FURTHER CONSEQUENCES WERE REPORTED.

  Patient problems: Perforation; Unspecified Tissue Injury

  MAUDE report 20166058 ↗
• MalfunctionDec 10, 2021Break; Break

  IT WAS REPORTED THAT DURING AN EXTERNAL FIXATION SURGERY, IT WAS FOUND THAT THE SURESHOT TARGETER WAS BROKEN. FREE HANDS WERE USED TO INSERT THE SCREWS FINALLY. THERE WAS A DELAY OF 30 MINUTES OR FEWER, AND THE PROCEDURE WAS FINISHED WITH A CHANGED IN SURGICAL TECHNIQUE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12979111 ↗
• MalfunctionDec 9, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING CLOSED REDUCTION AND INTERNAL FIXATION OF FEMUR SURGERY, AFTER CONNECTING TO THE HOST, A TRIGEN SURESHOT TARGETER DISPLAYED "SURESHOT TARGETER INVALID OR BROKEN TOOL, PLEASE EXCHANGE!" AND COULD NOT BE USED NORMALLY. THE FREE HANDS WERE USED TO COMPLETE THE SURGERY. AFTER THE IN VITRO TEST, IT WAS CONFIRMED THAT THERE IS NO NAVIGATION SIGNAL. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. ADDITIONAL ANESTHESIA WAS REQUIRED DUE TO THE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12972027 ↗
• MalfunctionNov 30, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, A SURESHOT TARGETER COULDN'T WORK, THE MALFUNCTION IS UNKNOWN. THE SCREEN DISPLAYED THE MESSAGE: "SURESHOT TARGETER INVALID OR BROKEN TOOL, PLEASE EXCHANGE!". SURGERY WAS RESUMED, WITH A CHANGE IN SURGICAL TECHNIQUE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12899657 ↗
• MalfunctionNov 6, 2021Failure to Read Input Signal; Defective Device; Failure to Read Input Signal; Defective Device

  IT WAS REPORTED THAT, DURING SURGERY, WHEN THE TARGETER WAS CONNECTED TO THE INTERFACE, AN ERROR MESSAGE "THE TARGETER IS INVALID OR BROKEN" WAS DISPLAYED. AFTER SEVERAL ATTEMPTS OF CONNECT/DISCONNECT, THE MESSAGE KEPT SHOWING. PROCEDURE WAS PERFORMED USING RADIOLUCENT, THE OPERATION WAS COMPLETED WITH A NON-SIGNIFICANT DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12755816 ↗
• InjurySep 20, 2021Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED DURING A COMPUTER-ASSISTED ORTHOPEDIC SURGERY THAT WHEN THE SURESHOT TARGETER WAS CONNECTED TO THE INTERFACE, AN ERROR MESSAGE SAYING DAMAGED TARGETER APPEARED. SURGERY WAS COMPLETED FREE HANDED, A DELAY OF 30 MINUTES IS REPORTED. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12494607 ↗
• InjuryJul 29, 2021Communication or Transmission Problem; Output Problem; Communication or Transmission Problem; Output Problem

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION PROCEDURE, A SURESHOT TARGETER HAD LOW QUALITY FIELD SIGNAL, ERROR MESSAGES ON THE SCREEN AND THIS RESULTED IN SCREWS BEING PULLED OUT OF THE NAIL. THE PROCEDURE WAS FINISHED WITHOUT DELAY SWITCHING TO A DIFFERENT SURGICAL TECHNIQUE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250760 ↗
• InjuryJun 24, 2021Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED THAT, DURING A SURGERY, A SURESHOT TARGETER SHOWED AN ERROR MESSAGE WHEN IT WAS CONNECTED TO THE INTERFACE (THE TARGETER WAS BROKEN). SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE (RADIOLUCENT DRILL). PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12063691 ↗
• InjuryMay 11, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT THE HOST COMPUTER SCREEN FOR THE SURESHOT TARGETER DISPLAYED AN "AIMING SURESHOT IS DAMAGED, PLEASE REPLACE WITH ANOTHER ONE" MESSAGE. IT IS UNKNOWN WHEN THE EVENT HAPPEN RELATIVE TO SURGERY. A CHANGED IN SURGICAL TECHNIQUE WAS REQUIRED TO COMPLETE THE PROCEDURE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11805773 ↗
• InjuryMay 6, 2021Fitting Problem; Connection Problem; Fitting Problem; Connection Problem

  IT WAS REPORTED THAT THE CABLE OF THE SURESHOT TARGETER WAS NOT ABLE TO CONNECT TO THE HOST MONITOR ("SURESHOT TARGETER NOT FOUND"). IT IS UNKNOWN IF THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVED. IT IS ALSO UNKNOWN IF THERE WAS ANY DELAYS AND IF THERE WAS A BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11783823 ↗
• InjuryApr 25, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIMENTED MULTIPLE DISLOCATIONS RECENTLY. THIS ADVERSE EVENT WAS ADDRESSED THROUGH REVISION SURGERY TO EXCHANGE LINER AND HEAD. GIVEN THAT THE SIZE OF R3 CUP IS 50 MM AND, THEREFORE, NOT ABLE TO TAKE A CONSTRAINED LINER, IT THE R3 CUP WAS ALSO REMOVED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11722121 ↗
• InjuryMar 15, 2021Break; Connection Problem; Break; Connection Problem

  IT WAS REPORTED THAT, WHILE USING A SURESHOT TARGETER, ,THE TARGETER WAS NOT WORKING, WHEN THE SOLENOID WAS CONNECTED, THERE WAS A BREAKAGE AND A CONNECTION FAILURE ERROR OCCURRED. THE PROCEDURE WAS COMPLETED CHANGING THE SURGICAL TECHNIQUE AND NO OTHER COMPLICATIONS WERE REPORTED. 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

  MAUDE report 11480461 ↗
• InjuryMar 15, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING USE, OUTSIDE THE PATIENT, WHILE USING A SURESHOT TARGETER IT DID NOT WORK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY WITH A CHANGE OF SURGICAL TECHNIQUE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. 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

  MAUDE report 11480428 ↗
• InjuryMar 1, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING USE, OUTSIDE THE PATIENT, THE DEVICE WAS NOT WORKING. THE PROCEDURE FINISHED WITH A CHANGE IN A SURGICAL TECHNIQUE. NO SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED. 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

  MAUDE report 11391121 ↗
• InjuryJan 29, 2021Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT, THE SURESHOT TARGETER HOST COMPUTER SCREEN REPORTED AN ERROR SAYING "SURESHOT TARGETER INVALID OR BROKEN TOOL, PLEASE EXCHANGE". THE PROCEDURE WAS COMPLETED BY CHANGING THE SURGICAL TECHNIQUE. THERE WAS A DELAY LESS THAN OR EQUAL TO 30MIN. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11250164 ↗
• InjuryJan 29, 2021Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT THE SURESHOT TARGETER HOST COMPUTED SCREEN REPORTED AN ERROR SAYING "AIMING SURESHOT IS DAMAGED, PLEASE REPLACE WITH ANOTHER ONE". THE PROCEDURE WAS COMPLETED BY CHANGING THE SURGICAL TECHNIQUE. THERE WAS A DELAY LESS THAN OR EQUAL TO 30MIN. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11250152 ↗
• InjuryJan 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, TARGETED DEVICE PLUGGED INTO SURESHOT SCREEN AND INDICATED TARGETER WAS BROKEN/INVALID. THERE WAS A CHANGE IN THE SURGICAL TECHNIQUE. THERE WAS NO DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11144571 ↗
• InjuryJan 4, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT, A SURESHOT TARGETER DID NOT DETECT ( FIND) THE SOLENOID. INCIDENT OCCURRED BEFORE THE PROCEDURE; THE PROCEDURE WAS FINISHED WITHOUT THE DEVICE, USING A DIFFERENT SURGICAL TECHNIQUE. NO OTHER COMPLICATIONS WERE REPORTED. 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

  MAUDE report 11107715 ↗
• InjuryDec 10, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT DURING SURGERY, THE SURESHOT DIDN'T WORK. THE PROCEDURE WAS FINISHED FREE HANDS TO INSERT THE SCREWS. IT IS UNKNOWN WHAT PROCEDURE WAS BEING PERFORMED. IT IS UNKNOWN IF THERE WAS A DELAY. NO INJURY OR HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10988423 ↗
• InjuryDec 10, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT DURING SURGERY, THE SURESHOT DIDN'T WORK. THE PROCEDURE WAS FINISHED FREE HANDS TO INSERT THE SCREWS. IT IS UNKNOWN WHAT PROCEDURE WAS BEING PERFORMED. IT IS UNKNOWN IF THERE WAS A DELAY. NO INJURY OR HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10988378 ↗
• InjuryDec 10, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT DURING SURGERY, THE SURESHOT DIDN'T WORK. THE PROCEDURE WAS FINISHED FREE HANDS TO INSERT THE SCREWS. IT IS UNKNOWN WHAT PROCEDURE WAS BEING PERFORMED. IT IS UNKNOWN IF THERE WAS A DELAY. NO INJURY OR HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10988253 ↗
• InjuryDec 8, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT, DURING SURGERY, THE SURESHOT DIDN'T WORK (FREE HANDS TO INSERT SCREW). THERE WAS A CHANGE IN THE SURGICAL PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED. 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

  MAUDE report 10967476 ↗
• InjuryDec 8, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT, DURING SURGERY, THE SURESHOT DIDN'T WORK. THERE WAS A CHANGE IN THE SURGICAL PROCEDURE (FREE HANDS WERE USED TO COMPLETE THE SURGERY). NO OTHER COMPLICATIONS WERE REPORTED. 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

  MAUDE report 10967466 ↗
• InjuryNov 27, 2020Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE, ONE OF THE SMALL CONNECTIONS OF THE SURESHOT TARGETER IN THE PLUG CONNECTING TO THE HOST COMPUTER WAS FOUND TO BE BROKEN AND CANNOT BE CONNECTED NORMALLY. THERE WAS A CHANGE IN TECHNIQUE DUE TO THIS MALFUNCTION. THERE WAS NO DELAY. FINISHED THE SURGERY SAFELY, PATIENT DISCHARGED FROM HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10912899 ↗