IMPACTOR PAD 0837Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00848665013559), received between Apr 26, 2023 and Jan 21, 2025 — classified as 7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2025Break; Break

  ON 12/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 1239-100 INSERTION GUIDE, AND 1255-300 TIBIAL INSERTION GUIDE MALFUNCTIONED. THIS OCCURRED DURING AN IM NAIL TIBIA PROCEDURE THE TIBIAL NAIL CONNECTION PIECE BROKE UPON IMPACTING THE NAIL DOWN. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION WAS PROVIDED ON 12/31/2024, WHERE THE SALES REPRESENTATIVE STATED THAT UPON IMPACTION OF THE TIBIAL NAIL, THE 0837-000 STRIKE PLATE BROKE OFF AND THE THREADS WERE COLD WELDED INTO THE CONNECTING PIECE. THE 1239-100 KNOB IN WHICH YOU CONNECT THE CARBON JIG TO IS ALSO COLD WELDED INTO THE 1255-300 INSERTER. THE PATIENT WAS RELATIVELY YOUNG WITH DECENTLY GOOD BONE QUALITY. THE SURGEON COMPLETED FINAL NAIL INSERTION BY IMPACTING DIRECTLY ON THE TIBIAL NAIL JIG. THERE WAS NO DELAY IN THE PROCEDURE AND NO ADDITIONAL ANESTHESIA TIME WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200390 ↗
• MalfunctionJan 6, 2025Break; Break

  ON 12/10/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 0837-000 IMPACTOR PAD AND AN 1255-300 SUPRAPATELLAR INSERTION GUIDE BROKE. AS A NAIL WAS BEING REAMED, THE JIG WAS HIT WITH THE IMPACTOR PAD AND BROKE OFF AT THE ATTACHMENT TO THE JIG. THIS WAS DISCOVERED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES AND THE NAIL WAS INSERTED NORMALLY. X-RAYS WERE CONFIRMED TO MAKE SURE NO METAL PIECES WERE LEFT INSIDE OF THE BODY. PROCEDURE WAS COMPLETED AS PLANNED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21085140 ↗
• MalfunctionJun 28, 2024Material Fragmentation; Material Fragmentation

  ON 5/31/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT A 0812-100 EASYOUT EXTRACTOR AND AN 0837-000 IMPACTOR PAD WERE THREADED INTO THE EXTRACTION TOOL, AND WHEN THE SURGEON WAS REMOVING THE IMPLANT, METAL SHAVINGS WERE EVERYWHERE FROM BOTH PIECES. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 6/4/2024: THE METAL SHAVINGS DID NOT GO INSIDE THE PATIENT BUT JUST INTO THE STERILE FIELD. ALL METAL SHAVINGS WERE REMOVED FROM THE STERILE FIELD, AND THE CASE WAS COMPLETED. THERE WAS NO CASE DELAY. THIS WAS DISCOVERED DURING A TIBIAL NAIL REMOVAL PROCEDURE. THE ISSUE HAD NO ADVERSE EFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632471 ↗
• MalfunctionJun 19, 2024Material Separation; Material Separation

  IT WAS REPORTED ON 12/08/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN 0837-000 IMPACTOR PAD BROKE OFF OF 1255-000 TIBIAL INSERTION GUIDE OUTSIDE OF THE PATIENT DURING INSERTION. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566545 ↗
• MalfunctionJun 12, 2024Break; Break

  IT WAS REPORTED ON 12/21/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN 0837-000 IMPACTOR PAD BROKE OFF INSIDE THE 1255-000 TIBIAL INSERTION GUIDE. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19518854 ↗
• MalfunctionSep 8, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A 0837-000 IMPACTOR PAD BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON A. (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17710266 ↗
• MalfunctionApr 26, 2023Break; Break

  ON 03/27/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN 0837-000 IMPACTOR PAD BROKE. THIS OCCURRED DURING A TIBIAL NAIL PROCEDURE ON 03/25/2023 DURING ONE OF THE MALLETING STRIKES THE PAD BROKE. THE THREADED PORTION OF THE PAD BROKE RIGHT OFF AT THE BASE AND THE SHAFT/IMPACTOR PAD ITSELF FELL OFF. WHEN BACK-SLAPPING TO CREATE COMPRESSION A FEW MINUTES LATER, THE THREADED PORTION CAME OUT OF THE "JIG".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16815477 ↗