NA L94010Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295325192), received between May 15, 2018 and Jul 28, 2025 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (15 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2025Break; Break

  IT WAS REPORTED THAT THE METAL FILINGS COMING OFF INSTRUMENT AFTER STERILIZATION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22631422 ↗
• MalfunctionJun 2, 2023Failure to Cut; Failure to Cut

  CALCAR MILLS ARE BLUNT, SURGEONS REQUESTING NEW ONES TO REAM CALCAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17049367 ↗
• MalfunctionJun 2, 2023Failure to Cut; Failure to Cut

  CALCAR MILLS ARE BLUNT, SURGEONS REQUESTING NEW ONES TO REAM CALCAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17049343 ↗
• MalfunctionJun 2, 2023Failure to Cut; Failure to Cut

  CALCAR MILLS ARE BLUNT, SURGEONS REQUESTING NEW ONES TO REAM CALCAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17049341 ↗
• MalfunctionJun 2, 2023Failure to Cut; Failure to Cut

  CALCAR MILLS ARE BLUNT, SURGEONS REQUESTING NEW ONES TO REAM CALCAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17049340 ↗
• MalfunctionJun 2, 2023Failure to Cut; Failure to Cut

  CALCAR MILLS ARE BLUNT, SURGEONS REQUESTING NEW ONES TO REAM CALCAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17049339 ↗
• MalfunctionNov 30, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE CORAIL REAMERS ARE BLUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15886705 ↗
• MalfunctionNov 18, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE REAMER IS DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15827217 ↗
• MalfunctionJul 7, 2022Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn

  IT WAS REPORTED THAT THE INSTRUMENTS ARE WORN. THERE HAS NOT BEEN ANY IMPACT TO PATIENTS AND THERE WAS A SURGICAL DELAY OF 5 MINUTES WHILE A NEW TRAY WAS OPENED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14945066 ↗
• MalfunctionJul 7, 2022Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn

  IT WAS REPORTED THAT THE INSTRUMENTS ARE WORN. THERE HAS NOT BEEN ANY IMPACT TO PATIENTS AND THERE WAS A SURGICAL DELAY OF 5 MINUTES WHILE A NEW TRAY WAS OPENED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14945038 ↗
• MalfunctionDec 21, 2021Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn

  SCREW DRIVER DAMAGED, NOT GRIPPING, EDGES WITH VISIBLE SIGNS OF WEAR CALCAR REAMERS NOT CUTTING, VISIBLE SIGNS OF WEAR WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES, IF YES, NUMBER OF MINUTES: 10. ACTION TAKEN WHEN EVENT OCCURRED? ANOTHER STEP OF INSTRUMENTS OPENED. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13054361 ↗
• MalfunctionDec 21, 2021Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn

  SCREW DRIVER DAMAGED, NOT GRIPPING, EDGES WITH VISIBLE SIGNS OF WEAR. CALCAR REAMERS NOT CUTTING, VISIBLE SIGNS OF WEAR. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. IF YES, NUMBER OF MINUTES: 10. ACTION TAKEN WHEN EVENT OCCURRED? ANOTHER STEP OF INSTRUMENTS OPENED. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13053901 ↗
• MalfunctionDec 21, 2021Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INSTRUMENTS DID NOT BREAK INTO TWO OR MORE PIECES AND THERE WAS NO SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13053113 ↗
• MalfunctionOct 4, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE CALCAR REAMERS ARE BLUNT. THERE WAS NOT A DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12569089 ↗
• MalfunctionSep 24, 2021Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn

  WE HAVE 2 CALCAR REAMERS THAT ARE BLUNT THROUGH WEAR AND TEAR AT BEDFORD HOSPITAL. THEY WERE USED DURING A PROCEDURE. THERE WAS NO DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12525832 ↗
• MalfunctionJul 13, 2021Failure to Cut; Failure to Cut

  THR CASE IT WAS REPORTED THAT THE CALCAR REAMER WAS BLUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12158041 ↗
• MalfunctionJul 8, 2020Dull, Blunt; Dull, Blunt

  TOTAL HIP REPLACEMENT; CALCAR REAMER BLUNT AND UNABLE TO BE SHARPENED. NO AE TO PATIENT.

  Patient problems: No Code Available

  MAUDE report 10247470 ↗
• MalfunctionAug 13, 2018Dull, Blunt; Dull, Blunt

  THR: (B)(6) HOSPITAL, (B)(6) 2018. BOTH OF THE CALCAR REAMERS WERE REPORTED BLUNT BY THE SURGEON DURING THE CASE. THERE WAS NO ADVERSE EVENT TO PATIENT OR DELAY IN SURGERY, AS WERE ABLE TO OPEN ANOTHER TRAY IMMEDIATELY AND USE A SHARPER REAMER FIT FOR PURPOSE. (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7776776 ↗
• MalfunctionMay 18, 2018Dull, Blunt; Dull, Blunt

  (B)(6) HOSPITAL; (B)(6) 2018. CALCAR ITEMS HAVE BEEN NOTED BY SURGEONS AND (B)(6) STAFF THAT THEY ARE BLUNT AND NOT MEETING STANDARDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7525237 ↗
• MalfunctionMay 15, 2018Dull, Blunt; Dull, Blunt

  (B)(6) 2018. CALCAR ITEMS HAVE BEEN NOTED BY SURGEONS AND CSSD STAFF THAT THEY ARE BLUNT AND NOT MEETING STANDARDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7513811 ↗
• MalfunctionMay 15, 2018Dull, Blunt; Dull, Blunt

  (B)(6) HOSPITAL, (B)(6) 2018. CALCAR ITEMS HAVE BEEN NOTED BY SURGEONS AND CSSD STAFF THAT THEY ARE BLUNT AND NOT MEETING STANDARDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7513809 ↗
• MalfunctionMay 15, 2018Dull, Blunt; Dull, Blunt

  (B)(6) 2018. CALCAR ITEMS HAVE BEEN NOTED BY SURGEONS AND CSSD STAFF THAT THEY ARE BLUNT AND NOT MEETING STANDARDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7513795 ↗