NA 351.76SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982193971), received between Aug 2, 2023 and Dec 5, 2023 — classified as 4 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS A 3.0 REAMING ROD. IT WAS A CYLINDRICAL TUBE. THE END WAS MISSING OFF IT AND NO PRODUCT WAS THERE. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 3.0MM REAMING ROD/950MM W/STRAIGHT BALL TIP - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18265948 ↗
• MalfunctionNov 28, 2023Break; Break

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 02-NOVEMBER-2023, THE REAMING ROD IN QUESTION WAS FOUND WITH A PLASTIC COMPONENT MELTED TO IT. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.0MM REAMING ROD/950MM W/STRAIGHT BALL TIP ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18218593 ↗
• MalfunctionSep 29, 2023Break; Break

  IT WAS REPORTED THAT A SURGEON REMOVED A TIBIAL NAIL ON (B)(6) 2023 BECAUSE OF A POSSIBLE INFECTION. THE NAIL WAS DIFFICULT TO REMOVE FOR VARIOUS REASONS. THE SURGEON WAS UNABLE TO CONNECT THE APPROPRIATE EXTRACTOR FOR THE EX LOCKING NAILS, AND THEREFORE HAD TO TRY MULTIPLE OPTIONS SUCH AS THE NON-SYNTHES SET, JAMMING TWO REAMING RODS, A NON-SYNTHES EXTRACTION HOOK, AND A NON-SYNTHES CONICAL EXTRACTOR, WHICH SUCCESSFULLY EXTRACTED THE NAIL. THE NON-SYNTHES EXTRACTION HOOK TIP BROKE OFF DISTALLY TO THE NAIL. THERE WERE ALREADY PREVIOUS UNKNOWN FRAGMENTS AS WELL FROM WHEN THE SURGEON WAS ATTEMPTING TO REMOVE A DIFFICULT INTERLOCKING SCREW. THE MOST DISTAL SCREW WAS BURIED IN BONE AND EVENTUALLY WAS KNOCKED OUT SUCCESSFULLY. ADDITIONALLY, ONE OF THE WRAPPERS OF A 3.0 REAMING ROD SPLIT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF 45 MINUTES. IT IS NOT KNOWN WHETHER THE FRAGMENTS WERE REMOVED FROM THE TIBIA. AFTER THE SURGERY, IT WAS NOTED IN THE STERILE PROCESSING DEPARTMENT THAT THE EXTRACTION SCREW THREADS HAVE BEEN DAMAGED. THIS REPORT INVOLVES ONE 3.0MM REAMING ROD/950MM W/STRAIGHT BALL TIP - STERILE. THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS THE POSSIBLE INFECTION

  Patient problems: Insufficient Information

  MAUDE report 17848295 ↗
• MalfunctionAug 2, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 THAT THE BALL TIP OF THE GUIDE WIRE WOULD NOT COME OUT OF THE NAIL. THE GUIDE WIRE WAS CAUGHT UP ON THE PROXIMAL PEEK PIECE IN THE NAIL. SURGEON HAD TO PULL OUT THE NAIL AND GET A NEW ONE. THERE WAS 30 MINUTES SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. FRAGMENTS WERE GENERATED AND IT WAS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 3.0 REAMING ROD/950 STR BALL TIP - SILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17440065 ↗