RADIOLUCENT TARGETING ARM, 125° TROCHANTERIC NAIL 1267-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00848665028652), received between Apr 29, 2024 and May 4, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Material Puncture/Hole

  ON 17-APR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 1267-100 TROCH NAIL JIG HAS A HOLE IN THE MIDDLE OF THE GREEN BUTTON THAT SHOULD BE SEALED. NOTICED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25070232 ↗
• MalfunctionJan 12, 2026Crack

  ON 22-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 1267-100 RADIOLUCENT TARGETING ARM CRACKED AT THE METAL INTERFACE ATTACHING TO THE NAIL DURING IMPACTING OF THE IMPACTOR PAD. THIS WAS DISCOVERED DURING A TROCHANTERIC NAIL PROCEDURE WITH NO PATIENT HARM. THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036029 ↗
• MalfunctionJan 2, 2026Break

  ON 11-DEC-2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT A 1267-100 125-DEGREE RADIOLUCENT TARGETING ARM BROKE WHILE THE SURGEON WAS TRYING TO REMOVE THE IMPACTOR PAD TO GET BETTER VISUALIZATION ON THE LATERAL X-RAY TO VERIFY PIN PLACEMENT DURING A CASE. THERE WERE NO ADVERSE EVENTS, AND THE CASE WAS FINISHED WITH NO ISSUES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23943544 ↗
• MalfunctionFeb 7, 2025Break; Positioning Failure; Break; Positioning Failure

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A 1267-100 RADIOLUCENT TARGETING ARM GREEN BUTTON WAS DEFECTIVE AND DID NOT HOLD THE SHEATH SECURELY AND A 5033-100 GALILEO CAPTURING ROD END SNAPPED OFF WHEN THE SURGEON UNSCREWED THE ROD. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21334318 ↗
• MalfunctionOct 2, 2024Break; Break

  ON 09/03/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT A 1267-100 RADIOLUCENT TARGETING ARM¿S METAL PIECE HAD BROKEN OFF OF THE CASE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 9/27/2024, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION VIA EMAIL: THE METAL PIN CAME OUT DURING A LAG SCREW REMOVAL/REPLACEMENT PROCEDURE. THE SURGEON EXPRESSED THAT THE TELESCOPING LAG SCREW WAS TOO LONG AND THE LAG SCREW DID NOT LOCK INTO THE NAIL FROM THE FIRST SURGERY THAT WAS PERFORMED ALMOST THREE MONTHS PRIOR, AND THE LAG SCREW WAS BACKING OUT. THE SURGEON ATTEMPTED TO PLACE THE JIG BACK ONTO THE TROCH NAIL WHICH WAS LOCATED INSIDE THE FEMUR FROM A PREVIOUS SURGERY. A 3.2 GUIDEWIRE WAS USED TO GUIDE THE JIG ONTO THE BACK OF THE NAIL. THE JIG WAS ROTATED SEVERAL TIMES TO TRY AND FULLY SEAT ONTO THE NAIL, BUT THERE WAS SOME GAPPING THAT THE SURGEON WAS NOT SATISFIED WITH. THE IMPACTOR PAD WAS ASSEMBLED TO THE JIG AND THE SURGEON TRIED TO MALLET THE JIG ONTO THE NAIL. A NAIL WAS PULLED TO SHOW THE SURGEON HOW THE SLOTS NEEDED TO LINE UP, AND AGAIN SEVERAL ATTEMPTS WERE MADE TO PLACE THE JIG. ONE OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352445 ↗
• MalfunctionJul 12, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A 1267-100 RADIOLUCENT TARGETING ARMS IMPACTOR PAD BROKE OUT OF THE JIG. THE ATTACHMENT FROM THE JIG IS STUCK ON AN 0826-000 IMPACTOR ROD. THIS OCCURRED DURING A CASE.

  Patient problems: Insufficient Information

  MAUDE report 19734083 ↗
• MalfunctionJun 13, 2024Break; Break

  ON 05/16/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 0826-000 IMPACTOR PAD DE-THREADED THE METAL COUPLING WHERE IT ATTACHES TO THE 125° JIG. AS A RESULT, THE IMPACTOR PAD COULD NOT BE THREADED INTO THE 130° JIG. WHILE USING THE 130° JIG, THE SLEEVES' RETAINING BUTTON WAS STICKING, PREVENTING THEM FROM HOLDING IN PLACE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19527611 ↗
• MalfunctionMay 24, 2024Unintended Movement; Unintended Movement

  ON 4/25/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A 1267-100 RADIOLUCENT TARGETING ARM WAS UNABLE TO KEEP THE LAG SCREW SHEATH TIGHT INSIDE THE JIG INSERTION HOLE. IT WAS STATED THAT THE JIG BUTTONS WERE "STICKING" AND NOT HOLDING THE OUTER SHEATH AS IT WAS PRIOR. THE CASE WAS COMPLETED WITH ALL STANDARD INSTRUMENTATION. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT AND NO DELAY IN THE CASE. THIS WAS DISCOVERED DURING A TROCHANTERIC NAIL FOR INTERTROCH FX PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19398026 ↗
• MalfunctionApr 29, 2024Positioning Failure; Defective Device; Positioning Failure; Defective Device

  ON 04/04/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 1267-100 TARGETING GUIDE WAS MISALIGNED. "THE 5.0 CORTICAL SCREW WAS HITTING THE NAIL AS THE SCREW ADVANCED. THE SCREW HEAD EVENTUALLY BROKE FROM THE THREADS ON ADVANCEMENT. WE PUT ANOTHER 5.0 CORTICAL SCREW IN THE DYNAMIC SLOT AND THE CASE WAS COMPLETED SUCCESSFULLY." THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ADDITIONAL INFORMATION REQUESTED FOR THE BROKEN SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19201344 ↗