NA SD352.110Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982005601), received between Nov 24, 2020 and Nov 24, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 24, 2020Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT 4 MEDULLARY REAMER HEAD FRONT CUTTING WERE PICKED UP FOR INSPECTION POST-OP AND WERE FOUND OUT DULL. THEY ARE NOT SHARP FOR REAMING. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR 1 11.0MM MEDULLARY REAMER HEAD FRONT CUTTING. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10891543 ↗
• MalfunctionNov 24, 2020Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT 4 MEDULLARY REAMER HEAD FRONT CUTTING WERE PICKED UP FOR INSPECTION POST-OP AND WERE FOUND OUT DULL. THEY ARE NOT SHARP FOR REAMING. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR 1 11.0MM MEDULLARY REAMER HEAD FRONT CUTTING. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10891510 ↗
• MalfunctionNov 24, 2020Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT 4 MEDULLARY REAMER HEAD FRONT CUTTING WERE PICKED UP FOR INSPECTION POST-OP AND WERE FOUND OUT DULL. THEY ARE NOT SHARP FOR REAMING. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR 1 11.0MM MEDULLARY REAMER HEAD FRONT CUTTING. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10891508 ↗
• MalfunctionNov 24, 2020Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT 4 MEDULLARY REAMER HEAD FRONT CUTTING WERE PICKED UP FOR INSPECTION POST-OP AND WERE FOUND OUT DULL. THEY ARE NOT SHARP FOR REAMING. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR 1 11.0MM MEDULLARY REAMER HEAD FRONT CUTTING. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10891493 ↗