IMPACTOR PAD 0826-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00848665002805), received between Oct 12, 2021 and Jan 26, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. 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.

• MalfunctionJan 26, 2026Physical Resistance/Sticking

  ON (B)(6) 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 24178209 ↗
• MalfunctionJan 2, 2026Break

  ON 11-DEC-2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN 0826-000 IMPACTOR PAD BROKE WHILE THE SURGEON WAS TRYING TO REMOVE IT 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 23943465 ↗
• MalfunctionApr 1, 2025Break; Break

  ON 03/11/2025, 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 21746351 ↗
• MalfunctionJun 14, 2024Damaged Thread; Damaged Thread

  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 19536715 ↗
• MalfunctionJun 5, 2024Damaged Thread; Damaged Thread

  IT WAS REPORTED ON 06/06/2022 BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN 0826-000 IMPACTOR PAD WAS CROSS THREADED ON AN 1268-100 TARGETING ARM, AND A 0616-000 OBTURATOR PIN GUIDE FELL APART. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM. PER FACILITY: "1 + 2. AFTER IMPACTING NAIL IN PATIENT WITH A MALLET, HITTING THE IMPACTOR PAD CONNECTED TO THE JIG; WE COULD NOT REMOVE THE IMPACTOR PAD FROM THE JIG. IT WAS VERY HARD AND EVENTUALLY WE WERE ABLE TO. HOWEVER, THERE WERE METAL SHAVINGS THAT WERE COMING OFF THE IMPACTOR, THE SURGEON SAID AND IT SEEMED TO HAVE CROSS-THREAD INTO THE METAL ON THE JIG. HOWEVER, AFTER THE CASE WHEN INSPECTING THE INSTRUMENTS, WE REALIZED THE PAD WAS STILL CONNECTED TO THE METAL RING USUALLY LOCATED ON THE NAIL JIG. THE IMPACTOR PAD/WITH THE METAL FROM THE NAIL JIG CAME OUT AS ONE PIECE. 3. WHEN REMOVING THE TROCAR/OBTURATOR FOR THE LAG SCREW PIN, THE KNOB ON THE END FELL OFF; SO WE HAD TO REMOVE THE ENTIRE SLEEVE TO TAKE OUT TROCAR AND THEN RE-ENTER SLEEVE FOR GUIDE PIN PLACEMENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19469096 ↗
• MalfunctionNov 30, 2023Defective Device; Defective Device

  ON 10/31/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06071356 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 18242755 ↗
• MalfunctionSep 14, 2023Break; Break

  ON 08/21/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A 0826-000 IMPACTOR ROD IS BROKEN. THIS OCCURRED DURING A CASE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17745981 ↗
• MalfunctionOct 12, 2021Break

  IT WAS REPORTED BY THE SALES REP THAT THE 0826-000 BROKE DURING A PROCEDURE. NO ADDITIONAL INFORMATION PROVIDED. FURTHER INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 6/9/21: PROCEDURE BEING PERFORMED WAS RETROGRADE FEMORAL NAIL FOR A DISTAL FEMORAL FRACTURE. THE DEVICE BROKE WHEN THE SURGEON WAS MALLETING IT LIGHTLY UPON INSERTION OF THE NAIL. THE DEVICE WAS REMOVED AND THE CASE WAS COMPLETED BY USING A LONGER IMPACTOR CAP THAT COME IN THE MAGELLAN TRAY.

  Patient problems: Insufficient Information

  MAUDE report 12615201 ↗