RADIOLUCENT TARGETING ARM, 130° TROCHANTERIC NAIL 1268-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00848665028645), received between Sep 1, 2023 and Aug 27, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Positioning Failure

  On (b)(6) 2026, it was reported by a sales Representative via (b)(6) that a 1268-100 targeting arm and 0315-100 drill guide are no longer targeting. Noticed during a case with no patient effect.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50473727 ↗
• MalfunctionMar 13, 2026Material Twisted/Bent

  ON 18-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 1268-100 TARGETING ARM WITH NOT STAY CENTERED TO ALLOW GUIDE WIRE TO PASS THROUGH. THE BUTTON IS ALSO LOOSE, WHICH IN TURN MAKES THE TRIPLE SLEEVE OFF-AXIS. NOTICED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589690 ↗
• MalfunctionJan 26, 2026Detachment of Device or Device Component; Physical Resistance/Sticking

  ON 09-JAN-2026, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT THE 0826-000 IMPACTOR PAD BECAME COLD-WELDED TO THE 1268-100 130-DEGREE RADIOLUCENT TARGETING ARM, AND UPON REMOVAL, THE METAL FITTING INSIDE THE TARGETING ARM CAME OUT WITH THE IMPACTOR PAD, RENDERING BOTH UNUSABLE. THE DAMAGE THAT WAS INCURRED PERHAPS ADDED 5 MINUTES ONTO THE CASE AND ADDITIONAL ANESTHESIA, BUT NO DIRECT HARM WAS DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24178210 ↗
• MalfunctionDec 3, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 11/13/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A 1268-100 130-DEGREE RADIOLUCENT TARGETING ARM GREEN ES BUTTON WAS DIFFICULT TO PRESS AND GOT STUCK. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706169 ↗
• MalfunctionOct 22, 2025Use of Device Problem; Failure to Advance; Use of Device Problem; Failure to Advance

  ON 10/14/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE FLIPCUTTER III FROM AN AR-1288RTIB-FC3 TIGHTROPE II RT WITH FIBERTAPE IB, FLIPCUTTER III, AND FIBERSTICK IMPLANT SYSTEM BROKE AND WAS UNABLE TO BE USED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 10/20/2025: DURING THE PROCEDURE, THE FLIPCUTTER BROKE WHILE RETRO DRILLING INSIDE THE PATIENT. FORTUNATELY, ALL FRAGMENTS WERE SUCCESSFULLY RETRIEVED WITHOUT COMPLICATION. TO COMPLETE THE CASE, AN INDIVIDUAL AR-1240FF FLIPCUTTER III WAS USED. THE INCIDENT DID NOT RESULT IN ANY SURGICAL DELAY, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23356330 ↗
• MalfunctionOct 17, 2025Failure to Advance; Failure to Advance

  ON 10/10/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT A 1268-100 RADIOLUCENT TARGETING ARM, 130 DEGREE TROCH NAIL, EXPERIENCED AN ISSUE. THE ES SCREW TRAJECTORY WAS INACCURATE, CAUSING THE SCREW TO BIND WITHIN THE NAIL. THE SCREW CROSS-THREADED, AND THE SURGEON WAS UNABLE TO FULLY ADVANCE IT THROUGH THE NAIL. AS A RESULT, THE ES SCREW REMAINED PROMINENT ON THE LATERAL CORTEX OF THE FEMUR. THE CASE WAS COMPLETED SUCCESSFULLY AND NO PIECE BROKE OFF IN THE PATIENT. THIS WAS IDENTIFIED DURING A TROCHANTERIC NAIL PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23325884 ↗
• MalfunctionSep 16, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ON 08/26/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT A COLD-WELDED JIG OF AN 0826-000 IMPACTOR PAD AND 1268-100 130-DEGREE TARGETING ARM BROKE OUTSIDE OF THE PATIENT DURING A TROCH NAIL PROCEDURE. NO PATIENT WAS AFFECTED. THE PROCEDURE WAS COMPLETED AS NORMAL, AND THE IMPACTOR WAS TAKEN OFF AT THE END. ADDITIONAL INFORMATION RECEIVED ON 9/8/2025 FROM SALES REP: IT WAS REPORTED THAT THE BREAK OCCURRED OUTSIDE OF THE PATIENT. NO FRAGMENTS WERE PRODUCED. THIS OCCURRED DURING A TROCH NAIL PROCEDURE AND WAS COMPLETED AS NORMAL AS THE IMPACTOR WAS JUST TAKEN OFF AT THE END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23062698 ↗
• MalfunctionApr 1, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 0826-000 IMPACTOR PAD HAD THE THREADS DAMAGED THE 1268-100 130° RADIOLUCENT TARGETING ARM. THERE WAS NO PATIENT EFFECT. THIS WAS DISCOVERED DURING A HIP FRACTURE PROCEDURE ON (B)(6)2025, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21746355 ↗
• MalfunctionMar 27, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 1268-100 130° RADIOLUCENT TARGETING ARM HAD THE GREEN BUTTON/SPRING BREAK WHEN THE DOCTOR WAS HAMMERING ON IT. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 03/14/2025: THEY COMPLETED THE CASE WITHOUT THE GREEN BUTTON ON THE JIG BY SHOVING THE TROCAR INTO THE JIG HOLE FIRMLY AND IT WENT IN WITHOUT THE BUTTON. THE CASE WAS DELAYED FOR ONE MINUTE. NO ADDED ANESTHESIA WAS ADMINISTERED, AND NO ADVERSE EFFECTS WERE REPORTED. THIS WAS DISCOVERED DURING A TROCH FX PROCEDURE ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708785 ↗
• MalfunctionMar 21, 2025Positioning Failure; Defective Device; Positioning Failure; Defective Device

  ADDITIONAL INFORMATION WAS RECEIVED ON 03/12/2025: THIS OCCURRED AT THE END OF THE CASE DURING A TROCH FX PROCEDURE ON (B)(6) 2025. THEY USED ANOTHER 1268-100 130° RADIOLUCENT TARGETING ARM AND A DIFFERENT HOLE TO COMPLETE THE CASE. THEY USED A DYNAMIC HOLE, NOT A STATIC ONE, TO COMPLETE THE CASE. THERE WAS NO CASE DELAY. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21663771 ↗
• MalfunctionFeb 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 02/10/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT A 1268-100 RADIOLUCENT TARGETING ARMS GREEN PLASTIC PUSH BUTTON POPPED OUT AND LANDED ON THE FLOOR. THIS OCCURRED DURING A PROCEDURE. ONCE THEY BEGAN TO INSERT THE NAIL OVER THE BALL NOSE GUIDE WIRE, THE SURGEON MALLETED THE IMPACTOR PAD TO ADVANCE THE NAIL. ON HIS FIRST STRIKE, THE GREEN PLASTIC PUSH BUTTON POPPED OUT AND LANDED ON THE FLOOR. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH NO ISSUES, AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21445458 ↗
• MalfunctionFeb 18, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 1268-100 TARGETING ARMS METAL PIECE THAT CONNECTS TO THE MALLET PAD UNTHREADED AND WE CAN NO LONGER ATTACH MALLET PAD. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. NO SHAVINGS WERE PRODUCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21395477 ↗
• MalfunctionFeb 18, 2025Positioning Failure; Positioning Failure

  ON 01/31/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 1268-100 TARGETING ARM IS MISALIGNED. PER FACILITY: "130 DEGREE TROCHANTERIC NAIL JIG THAT IS MISALIGNING WITH THE STATIC DISTAL INTERLOCK HOLE IN THE SHORT TROCHANTERIC NAIL. DIFFERENT OUTER SHEATHS HAVE BEEN USED AND WE¿VE HAD SAME RESULT. 3 OF THE LAST 4 CASES USING THIS JIG HAVE CAUSED SURGEON TO HAVE AN EXTREMELY DIFFICULT TIME GETTING DRILL BIT THROUGH THE STATIC SHORT NAIL HOLE. WHEN I WAS ABLE TO EVALUATE THE JIG AFTER THE CASE TODAY, IT APPEARS THAT THE 1268-100 JIG HAS SLIGHTLY MORE PLAY WITHIN THE BLACK JIG HOLE THAN THE 125 JIG DOES. MY BEST GUESS IS THE TOLERANCE MIGHT BE SLIGHTLY DIFFERENT AND CAUSING THE MISS. THERE HAS BEEN NO PATIENT INJURY. AND HE CAN EVENTUALLY GET THE DRILL BIT TO GO THROUGH THE NAIL, AND INSERT THE SCREW WITH NO ISSUE. HOWEVER, THIS IS AN UNDERSTANDABLE FRUSTRATION FOR THE SURGEON AND WE ARE WILLING TO DO ANYTHING TO CORRECT IT.". THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. CASE WAS ABLE TO BE COMPLETED USING THE JIG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21395314 ↗
• MalfunctionJan 13, 2025Positioning Failure; Defective Device; Positioning Failure; Defective Device

  ON 12/18/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT AN 1268-100 TARGETING ARM IS MALFUNCTIONING. THE NAIL AND LAG SCREW WERE NOT ALIGNING ON THE JIG. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

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

  MAUDE report 21143245 ↗
• MalfunctionDec 5, 2024Defective Device; Defective Device

  ON 11/06/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A 1268-100 RADIOLUCENT TARGETING ARM HAD THE SLOT FOR THE LAW SCREW BEING EXTREMELY LOOSE. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20853296 ↗
• MalfunctionOct 29, 2024Break; Break

  ON 10/11/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 1268-100 RADIOLUCENT TARGETING ARM HAD THE GREEN BUTTON ON THE JIG POPPED OFF ONTO THE FLOOR DURING IMPACTION. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20558053 ↗
• MalfunctionOct 9, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 1268-100 RADIOLUCENT TARGETING ARM, 130 DEGREE TROCH NAIL BROKE DURING A CASE DUE TO NORMAL WEAR AND TEAR; THE GREEN BUTTON POPPED OUT AND WOULD NOT FUNCTION PROPERLY. THE CASE WAS COMPLETED AS PLANNED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408425 ↗
• MalfunctionAug 12, 2024Component Missing; Component Missing

  ON 07/16/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT A 1268-100 TARGETING ARM WAS MISALIGNED AND REPEATEDLY MISSED THE LAG SCREW. AND A 0312-200 PIN GUIDE WAS GETTING STUCK IN THE SLEEVE SPRING. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19961205 ↗
• MalfunctionJul 18, 2024Positioning Failure; Positioning Failure

  ON 6/25/2024, A SALES REPRESENTATIVE VIA SEMS(B)(4) REPORTED THAT A 1268-100 RADIOLUCENT TARGETING ARM, 130 DEGREE TROCH NAIL HAD AN ISSUE. THE INSIDE SCREW THAT ACCEPTS THE 0826-000 IMPACTOR PAD CAME OUT OF THE ACTUAL JIG ITSELF AND IS ATTACHED TO THE IMPACTOR PAD AND WILL NOT COME LOOSE. THE PATIENT WAS NOT HARMED. A PHOTO IS PROVIDED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19770839 ↗
• MalfunctionFeb 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 01/17/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 1268-100 TARGETING ARM GREEN BUTTON CAME OFF THE JIG OF THE TROCH NAIL. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: Insufficient Information

  MAUDE report 18678747 ↗
• MalfunctionNov 30, 2023Defective Device; Defective Device

  ON 10/31/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 0826-000 IMPACTOR ROD AND A 1268-100 RADIOLUCENT TARGETING ARM WERE DAMAGED AND MALFUNCTIONED. THIS OCCURRED DURING A CASE WITH NO EFFECT ON THE PATIENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18241772 ↗
• MalfunctionOct 4, 2023Failure to Advance; Failure to Advance

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06022922 THAT AN 1268-100 TARGETING ARMS DRILL PIN SHEATH/GUIDE COULD NOT ADVANCE INTO AIMING ARM. THIS OCCURRED DURING A HIP FRACTURE ON (B)(6) 2023, THE SURGEON MALLETED THE SLEEVE INTO PLACE WITH THE OBTURATOR AND REMOVED IT TO ALLOW A LITTLE MORE PLAY. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17871311 ↗
• MalfunctionSep 1, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A 1268-100 RADIOLUCENT TARGETING ARM IS CRACKED. THIS OCCURRED DURING A TROCHANTERIC NAIL ON (B)(6) 2023, THE IMPACTOR PAD CRACKED THE 130° TROCHANTERIC NAIL RADIOLUCENT TARGETING ARM. THE SURGEON SUCCESSFULLY PIVOTED TO A 125° NAIL AND MATCHING 125° TARGETING ARM. THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17671081 ↗