NA 399.94Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886982203137), received between Nov 25, 2020 and Aug 14, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2025Break; Corroded; Break; Corroded

  IT WAS REPORTED THAT ON (B)(6), 2025, THERE WAS PITTING, SCORING, CHIPPING ON DEVICES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22803184 ↗
• MalfunctionOct 18, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 ONE OF THE FORCEPS TIPS SNAPPED OFF. THERE WAS NO SURGICAL DELAY DUE TO REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ALL THE FRAGMENTS WERE GENERATED. IT WAS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20482293 ↗
• MalfunctionMar 22, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE RATCHET COMPONENT OF THE FORCEPS IN QUESTION WERE BROKEN. THE ISSUE WAS DISCOVERED DURING ROUTINE INSPECTION, THERE WAS NO PROCEDURE INVOLVEMENT. THERE WAS NO PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A REDUCTION FORCEPS WITH POINTS RATCHET 174MM. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960134 ↗
• MalfunctionMar 22, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE RATCHET COMPONENT OF THE FORCEPS IN QUESTION WERE BROKEN. THE ISSUE WAS DISCOVERED DURING ROUTINE INSPECTION, THERE WAS NO PROCEDURE INVOLVEMENT. THERE WAS NO PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A REDUCTION FORCEPS WITH POINTS RATCHET 174MM. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960133 ↗
• MalfunctionMar 22, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE RATCHET COMPONENT OF THE FORCEPS IN QUESTION WERE BROKEN. THE ISSUE WAS DISCOVERED DURING ROUTINE INSPECTION, THERE WAS NO PROCEDURE INVOLVEMENT. THERE WAS NO PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A REDUCTION FORCEPS WITH POINTS RATCHET 174MM. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960131 ↗
• MalfunctionMar 22, 2024Break; Break

  IT WAS REPORTED THAT ON 08-MARCH-2024, THE RATCHET COMPONENT OF THE FORCEPS IN QUESTION WERE BROKEN. THE ISSUE WAS DISCOVERED DURING ROUTINE INSPECTION, THERE WAS NO PROCEDURE INVOLVEMENT. THERE WAS NO PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A REDUCTION FORCEPS WITH POINTS RATCHET 174MM. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960130 ↗
• MalfunctionMar 22, 2024Break; Break

  IT WAS REPORTED THAT ON 08-MARCH-2024, THE RATCHET COMPONENT OF THE FORCEPS IN QUESTION WERE BROKEN. THE ISSUE WAS DISCOVERED DURING ROUTINE INSPECTION, THERE WAS NO PROCEDURE INVOLVEMENT. THERE WAS NO PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A REDUCTION FORCEPS WITH POINTS RATCHET 174MM. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960129 ↗
• MalfunctionMar 22, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE RATCHET COMPONENT OF THE FORCEPS IN QUESTION WERE BROKEN. THE ISSUE WAS DISCOVERED DURING ROUTINE INSPECTION, THERE WAS NO PROCEDURE INVOLVEMENT. THERE WAS NO PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A REDUCTION FORCEPS WITH POINTS RATCHET 174MM. THIS IS REPORT 1 OF 6 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960127 ↗
• MalfunctionOct 24, 2023Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE HANDLE PART OF THE PRODUCT IN QUESTION WAS BROKEN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A REDUCTION FORCEPS WITH POINTS RATCHET 174MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17995839 ↗
• MalfunctionMay 10, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TWO (2) REDUCTION FORCEP POINTS RACHET, PROTECTION SLEEVE, TROCAR, SHARP HOOK, INSERTION GUIDE, TWO (2) T-HANDLE WITH QUICK COUPLING, SCREWDRIVER SHAFT, DRIVING CAP AND RADIOLUCENT INSERTION HANDLE WERE FOUND DAMAGED AFTER USE IN SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT INVOLVES ONE (1) REDUCTION FORCEPS WITH POINTS RATCHET 174MM. THIS IS REPORT 4 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14345588 ↗
• MalfunctionFeb 4, 2022Break; Break

  IT WAS REPORTED THAT THE REPORTED EVENT OCCURRED DURING TIBIAL NAILING PROCEDURE. NO BROKEN FRAGMENTS RETAINED IN THE PATIENT. THE PATIENT AND PROCEDURE OUTCOME IS REPORTED AS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13453237 ↗
• MalfunctionFeb 4, 2022Break; Break

  IT WAS REPORTED THAT THE REPORTED EVENT OCCURRED DURING TIBIAL NAILING PROCEDURE. NO BROKEN FRAGMENTS RETAINED IN THE PATIENT. THE PATIENT AND PROCEDURE OUTCOME IS REPORTED AS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13453227 ↗
• MalfunctionFeb 4, 2022Break; Break

  IT WAS REPORTED THAT THE REPORTED EVENT OCCURRED DURING TIBIAL NAILING PROCEDURE. NO BROKEN FRAGMENTS RETAINED IN THE PATIENT. THE PATIENT AND PROCEDURE OUTCOME IS REPORTED AS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13453223 ↗
• MalfunctionFeb 4, 2022Break; Break

  IT WAS REPORTED THAT THE REPORTED EVENT OCCURRED DURING TIBIAL NAILING PROCEDURE. NO BROKEN FRAGMENTS RETAINED IN THE PATIENT. THE PATIENT AND PROCEDURE OUTCOME IS REPORTED AS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13453214 ↗
• MalfunctionDec 15, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CLAMP WAS BROKEN. IT IS UNKNOWN HOW THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THIS REPORT IS FOR A REDUCTION FORCEPS WITH POINTS RATCHET 174MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13010917 ↗
• MalfunctionJul 6, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE REDUCTION FORCEPS POINTS RATCHET WAS LOOSE. THERE WAS NO PATIENT INVOLVEMENT. UPON MANUFACTURER RECEIPT AND INVESTIGATION, IT WAS DETERMINED THAT THE DEVICE WAS BROKEN. THIS REPORT IS FOR A REDUCTION FORCEPS WITH POINTS RATCHET 174MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12121054 ↗
• MalfunctionNov 25, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE REDUCTION FORCEPS WITH POINTS RACHET HANDLE WAS BROKEN IN TWO PIECES. IT IS UNKNOWN HOW THE ISSUE WAS DISCOVERED. THERE IS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS WITH POINTS RATCHET 174MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10905299 ↗