TRIGEN 71692809Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010648235), received between Nov 5, 2020 and Feb 12, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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.

• MalfunctionFeb 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TIBIAL OSTEOSYNTHESIS, AFTER PLACING THE NAIL AND THE DISTAL SCREWS AS INDICATED BY THE TECHNIQUE, THE SURGEON PROCEEDED TO PLACE THE PROXIMAL SCREW WHICH WAS PLACED WITHOUT PROBLEMS. WHEN TRYING TO PLACE THE SECOND PROXIMAL SCREW, THE SURGEON TRIED TO PLACE THE SCREW WITH THE MOTOR AND HE FEELS THAT HE WAS NOT SECURING, HE TAKES THE SURE SHOT HEXDRIVER AND TRIED TO DO IT MANUALLY AND IN THAT MOVEMENT THE HEAD OF THE SCREW ROLLED, HE KEEPS TRYING AND IN ONE MOVEMENT THE TIP OF THE SURESHOT HEXDRIVER BROKE, THE SURGEON MUST USE A FORCEPS TO REMOVE THE SCREW. NO DAMAGE CAUSED, PATIENT'S HEALTH CONDITION IS STABLE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH COMPETITOR DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18684695 ↗
• MalfunctionSep 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT, THE TIP OF CAPTURE ROD OF THE SURESHOT HEXDRIVER BROKE OFF. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397445 ↗
• MalfunctionJun 19, 2022Fracture; Fracture

  IT WAS REPORTED THAT, THE SURESHOT HEXDRIVER RETAINING ROD SHEARED OFF TOWARD THE THREADS. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14741397 ↗
• MalfunctionMar 29, 2022Break; Break

  IT WAS REPORTED THAT SURESHOT HEXDRIVER BROKE WITHIN SCREW. IT IS UNKNOWN IF THIS WAS NOTICED DURING SURGERY OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: Insufficient Information

  MAUDE report 13935900 ↗
• MalfunctionJan 10, 2022Break; Break

  IT WAS REPORTED THAT THE INNER SLEEVE OF A SURESHOT HEXDRIVER BROKE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED RELATIVE TO THE SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13205505 ↗
• MalfunctionApr 15, 2021Break; Break

  IT WAS REPORTED THAT, ON INSPECTION THE CONNECTING END OF A SURE SHOT HEXDRIVER IS SEEN TO BE BROKEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11671753 ↗
• MalfunctionMar 4, 2021Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE THE LAG SCREW LENGTH GAUGE ((B)(4)) AND THE SURESHOT HEXDRIVER ((B)(4)) WERE NOTICED BROKEN. THE DEVICES BROKE OUTSIDE THE PATIENT. NO DELAY OR INJURY REPORTED. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408835 ↗
• MalfunctionNov 5, 2020Break; Break

  IT WAS REPORTED THAT THE SURESHOT HEXDRIVER WAS FOUND TO BE BROKEN IN THE TRAY. NO CASE RELATED, THEREFORE NO PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10795823 ↗

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