NA 03.233.010SRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982291844), received between Dec 11, 2023 and Apr 17, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 16, 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.

• MalfunctionApr 17, 2026Break

  IT WAS REPORTED THAT REAM ROD / 3.8 BALL TIP 3.0 / 950 -S HAD AN ISSUE WHERE THE PLASTIC COVERING OVER EACH END APPEARED TO BE MELTED ONTO THE GUIDE ROD. THE EVENT OCCURRED INTRA-OPERATIVELY. THERE WAS NO REPORTED CONSEQUENCE OR IMPACT TO THE PATIENT, AND NO SIGNS, SYMPTOMS, OR PATIENT INVOLVEMENT WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24910403 ↗
• MalfunctionOct 24, 2025Break; Break

  IT WAS REPORTED THAT IN (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH A NAIL FOR THE TIBIAL SHAFT FRACTURES AT ANOTHER HOSPITAL. THE NAIL WAS A COMPETITOR¿S NAIL. AFTER THE SURGERY, THE NAIL WAS REMOVED AT THE END OF (B)(6) 2024. HOWEVER, AT THIS STAGE, THE FRACTURES DID NOT APPEAR TO HAVE HEALED COMPLETELY. LATER, THE AFFECTED AREA BECAME NON-UNION. IT IS UNCLEAR WHY THE NAIL WAS REMOVED. ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY WITH TNA FOR THE NON-UNION. SINCE A 10MM NAIL WAS USED FOR THE FIRST SURGERY, A 12MM NAIL WAS PLANNED TO BE USED. DURING THE SURGERY, AN ATTEMPT WAS MADE TO PASS A REAMING ROD THROUGH THE NON-UNION PART, BUT IT COULD NOT BE PASSED BECAUSE THE BONE HAD FILLED IN. THE SURGEON TRIED TO ADVANCE THE REAMING ROD BY TAPPING, BUT IT STILL WOULDN'T GO THROUGH, SO REAMING WAS PERFORMED, AND THE REAMING ROD GRADUALLY ADVANCED LITTLE BY LITTLE. WHILE REAMING, THE REAMER SHAFT AND ROD BROKE OFF. APPROXIMATELY 15 CM OF THE BROKEN PORTION REMAINED IN THE MEDULLARY CAVITY, BUT IT WAS REMOVED USING HERNIA FORCEPS. THE SURGERY CONTINUED, A 12 MM-285 MM NAIL WAS INSERTED, AND A DRILLING WAS PERFORMED FOR PROXIMAL LOCKING. HOWEVER, THE DRILL BIT INTERFE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23377366 ↗
• MalfunctionMar 5, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT FEBRUARY 18, 2024, FOR A WOJCIK CASE OF A TIBIAL NAIL, THE CAPS STUCK ON THE GUIDE ROD PRE-OPERATIVELY. THE RESIDUAL DEBRIS WERE LEFT WHEN REMOVING THE ROD. THE ROD WAS REJECTED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE REAMING ROD / Ø 3.8MM BALL TIP Ø 3.0MM / 950MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838966 ↗
• MalfunctionFeb 1, 2024Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6)2024, PLASTIC CAP STUCK AND LEAVES RESIDUAL PRODUCT WHEN REMOVED. SURGEON REJECTED. THERE WAS NO DELAY IN CASE. PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) REAM ROD / 3.8 BALL TIP 3.0 / 950 -S THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18622171 ↗
• MalfunctionJan 12, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SILICONE WAS MELTED. THERE WERE NO PATIENT OUTCOMES REPORTED. THERE WAS NO OTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) REAMROD Ø3 L950 W/BALL TIP Ø3.8. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18505376 ↗
• MalfunctionDec 15, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE BALL TIPPED WIRE IN QUESTION HAD MELTED SILICON. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A REAMING ROD / Ø 3.8MM BALL TIP Ø 3.0MM / 950MM ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18336050 ↗
• MalfunctionDec 15, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE BALL TIPPED WIRE IN QUESTION HAD MELTED SILICON. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A REAMING ROD / Ø 3.8MM BALL TIP Ø 3.0MM / 950MM ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18335998 ↗
• MalfunctionDec 11, 2023Break; Difficult to Open or Remove Packaging Material; Break; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING AN PROCEDURE, SURGICAL STAFF WAS NOT ABLE TO REMOVE THE RUBBER/SILICONE PROTECTIVE CAPS OFF THE END OF A 3.0MM REAMING ROD. THE STAFF TRIED TO REMOVE IT BY PULLING BUT THEY WERE UNSUCCESSFUL. ULTIMATELY, THEY USED A KNIFE TO CUT THE PROTECTIVE CAPS OFF. THE CAP NEAR THE BALL-TIP END OF THE REAMING ROD LEFT RESIDUAL PIECES ON THE REAMING ROD WHICH WERE EVEN MORE DIFFICULT TO REMOVE. THE SURGEON ULTIMATELY DEEMED THE ROD SAFE TO USE. A SECOND REAMING ROD WITH DIFFERENT LOT NUMBER WAS OPENED BUT RAN INTO THE SAME ISSUE. THAT SECOND ROD WAS PASSED OFF THE FIELD SO THAT IT COULD BE RETURNED AS PART OF THIS COMPLAINT. THE FRAGMENTS CREATED WERE REMOVED, BUT IT WAS NOT EASY TO REMOVE THEM. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF 10 MINUTES. THIS REPORT INVOLVES ONE (1) REAMING ROD / Ø 3.8MM BALL TIP Ø 3.0MM / 950MM - STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18302535 ↗
• MalfunctionDec 11, 2023Break; Difficult to Open or Remove Packaging Material; Break; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING AN PROCEDURE, SURGICAL STAFF WAS NOT ABLE TO REMOVE THE RUBBER/SILICONE PROTECTIVE CAPS OFF THE END OF A 3.0MM REAMING ROD. THE STAFF TRIED TO REMOVE IT BY PULLING BUT THEY WERE UNSUCCESSFUL. ULTIMATELY, THEY USED A KNIFE TO CUT THE PROTECTIVE CAPS OFF. THE CAP NEAR THE BALL-TIP END OF THE REAMING ROD LEFT RESIDUAL PIECES ON THE REAMING ROD WHICH WERE EVEN MORE DIFFICULT TO REMOVE. THE SURGEON ULTIMATELY DEEMED THE ROD SAFE TO USE. A SECOND REAMING ROD WITH DIFFERENT LOT NUMBER WAS OPENED BUT RAN INTO THE SAME ISSUE. THAT SECOND ROD WAS PASSED OFF THE FIELD SO THAT IT COULD BE RETURNED AS PART OF THIS COMPLAINT. THE FRAGMENTS CREATED WERE REMOVED, BUT IT WAS NOT EASY TO REMOVE THEM. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF 10 MINUTES. THIS REPORT INVOLVES ONE (1) REAMING ROD / Ø 3.8MM BALL TIP Ø 3.0MM / 950MM - STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18302455 ↗