TRIGEN 71692815Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010648150), received between Sep 4, 2018 and Aug 25, 2025 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K100107); they may or may not involve this specific model.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2025Break; Improper or Incorrect Procedure or Method; Device Damaged by Another Device; Break; Improper or Incorrect Procedure or Method; Device Damaged by Another Device

  IT WAS REPORTED THAT, DURING SURGERY, WHEN PERFORMING THE PROXIMAL BLOCK, THE DOCTOR DIDN'T REALIZE HE NEEDED TO REMOVE THE SURESHOT PERC TAN/FAN DRILL GUIDE PROBE USED FOR THE DISTAL BLOCK. THE DOCTOR DRILLED THE HOLE WITH THE DRILL BIT AND SEVERED THE PROBE. WHEN INSERTING THE NAIL INTO THE FEMORAL CANAL ON THE FIRST ATTEMPT, IT BECAME BLOCKED AT THE FRACTURE SITE, AND THEY HAD TO REAM THE CANAL FURTHER TO ALLOW IT TO PASS. FOR THIS REASON, THE DOCTOR REFUSED TO REMOVE THE NAIL AND DECIDED TO LEAVE THE PROBE INSIDE THE NAIL. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22884550 ↗
• MalfunctionSep 29, 2021Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT, DURING A INTERNAL FIXATION SURGERY, THE SURESHOT PERC TAN/FAN DRILL GUIDE PROBE COULD NOT BE IDENTIFIED, THE SURESHOT SCREEN DISPLAYED A INVALID OR BROKEN SENSOR ERROR. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12551056 ↗
• MalfunctionAug 25, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A SURESHOT PERC TAN/FAN DRILL GUIDE PROBE WAS OPENED AND CONNECTED TO THE TRAUMA INTERFACE, BUT IT DID NOT WORK, THE INTERFACE DISPLAYED THE FOLLOWING ERROR IN RED COLOR: ¿SURESHOT PROBE INVALID OR BROKEN SENSOR¿. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12367527 ↗
• InjuryApr 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) REF# (B)(4). IT WAS REPORTED THAT, DURING A TRIGEN MRTA TAN SURGERY, THE SURESHOT PERC TAN/FAN DRILL GUIDE PROBE WAS NOT REMOVED BEFORE DRILLING THE LAG SCREW. IT WAS FOUND WHILE DRILLING. THEN THE PROBE WAS REMOVED. HOWEVER, THE TIP OF THE PROBE BROKE INTO 2 PIECES INSIDE THE NAIL. ONE PIECE WAS INSIDE THE NAIL AND THE OTHER WAS LEFT INSIDE THE FEMORAL HEAD. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS ONE HOUR OF SURGICAL DELAY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11627510 ↗
• MalfunctionSep 22, 2020Application Program Problem; Application Program Problem

  IT WAS REPORTED THAT DURING USE INSTRUMENTS INSIDE THE PATIENT THE SURESHOT PERC TAN/FAN DRILL GUIDE PROBE DID NOT RECOGNIZE THE PROBE, THERE WAS A DELAY LEES THAN 30 MINUTES. THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10570348 ↗
• InjuryMay 2, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING SURGERY, THE SURGEON WAS USING THE SURESHOT WITH META-TAN NAIL, AND MISSED THE HOLE TWICE. TWO ADDITIONAL 4.0MM HOLES WERE PERFORATED IN THE PATIENT'S FEMUR. THERE WAS NO BACKUP DEVICE AVAILABLE AND THE PROCEDURE WAS DELAYED NO MORE THAN 30 MINUTES DUE TO THE SURGEON HAD TO DRILL THE HOLES USING THE FREEHAND TECHNIQUE WITHOUT THE SURESHOT. THERE IS NO PATIENT DATA AVAILABLE TO PROVIDE FOR CLINICAL INVESTIGATION.

  Patient problems: Injury

  MAUDE report 8573261 ↗
• MalfunctionNov 12, 2018Break; Break

  IT WAS REPORTED THAT A NEW PROBE WAS BROKEN AND CAN'T BE USED, RESULTING IN THE PROCEDURE DELAY GREATER THAN THIRTY MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8061390 ↗
• MalfunctionSep 4, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT GREEN AND RED CIRCLES ARE CONCENTRIC ON THE INTERFACE DISPLAY, BUT THE DRILL GOT TO OUT OF THE HOLE. TEN MIN DELAY IN OPERATION WAS REPORTED. TO COMPLETE THE SURGERY THE DOCTOR USED A COMPETITOR'S DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7842688 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100107. One submission often covers many models, so check the product and lot details in each record.

• Z-0411-2011 · Oct 15, 2010 · Terminated
  smith & nephew TRIGEN SURESHOT Distal Targeting System, Trauma Interface, V2.0.2, Trauma Launcher V1.01.1 Product is intended to be an intraoperative image-guided localization syst