SURESHOT 71692851Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556584620), received between Jan 6, 2021 and Sep 2, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Connection 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionSep 2, 2024Crack; Degraded; Crack; Degraded

  IT WAS REPORTED THAT DURING THE TRAUMA PROCEDURE, THE SURESHOT TARGETER'S CABLE WAS IN POOR CONDITION AND HAD CRACKS. AFTER CONNECTING TO THE CONSOLE, A WARNING OF INTERFERENCE APPEARED IN THE FIELD. THE PROCEDURE WAS COMPLETED AFTER A SIGNIFICANT DELAY (GREATER THAN 30MINS) BY CHANGE IN SURGICAL TECHNIQUE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20118278 ↗
• MalfunctionJun 20, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING PROCEDURE, THE SURESHOT TARGETER - 2ND GENERATION WAS NOT DETECTED. IT MAY BE BROKEN. SURGERY WAS PERFORMED AFTER A DELAY GREATER THAN 30 MIN, CHANGING SURGICAL TECHNIQUE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19575802 ↗
• MalfunctionFeb 23, 2024Imprecision; Imprecision

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION PROCEDURE, WHEN DRILLING USING ONE (1) SURE SHOT TARGETER - 2ND GENERATION, BOTH THE RED AND THE GREEN RING WERE FULLY WITHIN THE THE HOLE OF THE MODEL-NAIL ON DISPLAY. HOWEVER, THE ACTUAL DRILL DID NOT TARGET THE SCREW ON THE ACTUAL NAIL. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT (10 MIN) DELAY, BY CHANGING IN RADIOLUCENT DRILL. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18769252 ↗
• InjuryJun 8, 2021Failure to Analyze Signal; Failure to Analyze Signal

  IT WAS REPORTED THAT THE SURESHOT TARGETER: 2ND GENERATION HAD NO SIGNAL ON THE MONITOR. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, CHANGING IN SURGICAL TECHNIQUE. NO PATIENT INJURIES AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11962436 ↗
• MalfunctionFeb 19, 2021Display or Visual Feedback Problem; Material Deformation; Display or Visual Feedback Problem; Material Deformation

  IT WAS REPORTED THAT ONE OF THE SPIKES BENT INSIDE THE CONNECTOR. ONCE CONNECTED INTO MONITOR, IT INDICATES FALSE OR BROKEN TARGETER. THE EVENT OCCURRED DURING SURGERY. IT IS UNKNOWN IF/HOW THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11347205 ↗
• InjuryJan 6, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING SURGERY THE SOLENOID DID NOT DETECT THE EXACT HOLE DURING USE. THERE WAS A DELAY GREATER THAN 30 MIN. NO BACK UP APPLICABLE FOR THIS EVENT SINCE SURGEON COMPLETED THE PROCEDURE WITHOUT THE DEVICE. NO INJURIES OR OTHER COMPLICATIONS REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11124408 ↗