NA SD03.010.093Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982002570), received between Dec 2, 2020 and Apr 28, 2026 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE CABLE PASSER WAS JAMMED WHERE IT CANNOT BE LOCKED OR UNLOCKED. THE ROD PUSHERS ARE ALL BROKEN AT THE TIP AND TOWARDS THE END WILL NOT FIT IN THE REAMERS. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020481 ↗
• MalfunctionDec 11, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY AND THE SURGERY WAS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23782321 ↗
• MalfunctionMay 21, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A NONUNION HUMERUS, THE HUMERUS WAS RIA¿D. DURING RIA SURGEON PUT STIMULAN IN THE CANAL, THE CEMENT CLOGGED THE RIA 2 SHAFTS. BOTH THE INSTRUMENTS IN THE SET WERE USED. BOTH FILLED WITH CEMENT. THE SURGEON TRIED TO PUSH THE SD OPERATOR THROUGH AND THEY BOTH BENT AND BROKE OFF. MULTILOC GRAPHIC CASES AND RIA 2 GRAPHIC CASES WERE SPLATTERED WITH CEMENT AND UNABLE TO BE REMOVE. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) REAMING ROD PUSH ROD 2.5MM SHAFT. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19367159 ↗
• MalfunctionMay 21, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A NONUNION HUMERUS, THE HUMERUS WAS RIA¿D. DURING RIA SURGEON PUT STIMULAN IN THE CANAL, THE CEMENT CLOGGED THE RIA 2 SHAFTS. BOTH THE INSTRUMENTS IN THE SET WERE USED. BOTH FILLED WITH CEMENT. THE SURGEON TRIED TO PUSH THE SD OPERATOR THROUGH AND THEY BOTH BENT AND BROKE OFF. MULTILOC GRAPHIC CASES AND RIA 2 GRAPHIC CASES WERE SPLATTERED WITH CEMENT AND UNABLE TO BE REMOVE. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) REAMING ROD PUSH ROD 2.5MM SHAFT THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19367149 ↗
• MalfunctionMay 1, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING THE STERILIZATION PROCESS THE INSTRUMENTS WERE DAMAGED. THEY WERE BENT TO THE POINT THAT THEY BROKE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A REAMING ROD. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220279 ↗
• MalfunctionMay 1, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING THE STERILIZATION PROCESS THE INSTRUMENTS WERE DAMAGED. THEY WERE BENT TO THE POINT THAT THEY BROKE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A REAMING ROD. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220254 ↗
• MalfunctionJan 19, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2020, TWO (2) AUTO-ADJUSTING DRIVE ADAPTOR BROKE DURING SURGERY, TWO (2) SCREWDRIVERS STRIPPED DURING A PROCESS OF SCREW, THE SCREW INTERLOCK WITH THE SCREW HEAD AND WAS STRIPPED., AND TWO (2) REAMING ROD PUSH ROD 2.5MM SHAFT BROKE OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH SURGICAL DELAY OF 5 MINUTES. THERE WERE NO FRAGMENTS GENERATED. THERE WAS PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT INVOLVES ONE (1) REAMING ROD PUSH ROD 2.5MM SHAFT. THIS REPORT IS 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11194797 ↗
• MalfunctionDec 2, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE OPERATOR BROKE OFF THE REAMING ROD PUSH ROD 2.5MM SHAFT WHEN INSERTING INTO POWER. THERE WAS AN UNSPECIFIED AMOUNT OF SURGICAL DELAY. THE SURGERY WAS COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN INSERTION INSTRUMENTS: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR 1 REAMING ROD PUSH ROD 2.5MM SHAFT. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10936213 ↗
• MalfunctionDec 2, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE OPERATOR BROKE OFF THE REAMING ROD PUSH ROD 2.5MM SHAFT WHEN INSERTING INTO POWER. THERE WAS AN UNSPECIFIED AMOUNT OF SURGICAL DELAY. THE SURGERY WAS COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN INSERTION INSTRUMENTS: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR 1 REAMING ROD PUSH ROD 2.5MM SHAFT. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10936133 ↗
• MalfunctionDec 2, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6), 2020, THE OPERATOR BROKE OFF THE REAMING ROD PUSH ROD 2.5MM SHAFT WHEN INSERTING INTO POWER. THERE WAS AN UNSPECIFIED AMOUNT OF SURGICAL DELAY. THE SURGERY WAS COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN INSERTION INSTRUMENTS: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR 1 REAMING ROD PUSH ROD 2.5MM SHAFT. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10936096 ↗