SUMMIT 2570-02-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295142997), received between Dec 4, 2018 and Oct 29, 2024 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (11 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2024Failure to Cut; Failure to Cut

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAYS OR NEGATIVE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20556602 ↗
• MalfunctionOct 29, 2024Failure to Cut; Failure to Cut

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAYS OR NEGATIVE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20556529 ↗
• MalfunctionOct 11, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP SURGERY ON OCTOBER 4, 2024. THE HOSPITAL STAFF DROPPED THE BIPOLAR RETAINING CLIP ON THE FLOOR AND THREW IT IN THE TRASH. ALSO, THE SUMMIT REAMERS HAVE BECOME DULL. THIS DID NOT DELAY SURGERY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20429581 ↗
• MalfunctionOct 11, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP SURGERY ON (B)(6) 2024. THE HOSPITAL STAFF DROPPED THE BIPOLAR RETAINING CLIP ON THE FLOOR AND THREW IT IN THE TRASH. ALSO, THE SUMMIT REAMERS HAVE BECOME DULL. THIS DID NOT DELAY SURGERY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20429576 ↗
• MalfunctionOct 11, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP SURGERY ON (B)(6) 2024. THE HOSPITAL STAFF DROPPED THE BIPOLAR RETAINING CLIP ON THE FLOOR AND THREW IT IN THE TRASH. ALSO, THE SUMMIT REAMERS HAVE BECOME DULL. THIS DID NOT DELAY SURGERY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20429568 ↗
• MalfunctionMar 20, 2020Dull, Blunt; Failure to Cut; Material Twisted/Bent; Illegible Information; Dull, Blunt; Failure to Cut; Material Twisted/Bent; Illegible Information

  SIZE ETCHINGS ARE WORN AND NOT LEGIBLE, AND EDGES ARE DULL AND NOT ADEQUATE IN CUTTING BONE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9859644 ↗
• MalfunctionMar 20, 2020Dull, Blunt; Failure to Cut; Material Twisted/Bent; Illegible Information; Dull, Blunt; Failure to Cut; Material Twisted/Bent; Illegible Information

  SIZE ETCHINGS ARE WORN AND NOT LEGIBLE, AND EDGES ARE DULL AND NOT ADEQUATE IN CUTTING BONE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9859624 ↗
• MalfunctionFeb 5, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SUMMIT STRAIGHT REAMER SIZES 0-1,2-3,4-5,6-7,8-9, AND LATERALIZER ARE STRIPPED AT THE TOP AND WILL NOT WORK PROPERLY IN THE HUDSON ADAPTOR. NO PIECES ARE BROKEN AND ALL PARTS WERE RETRIEVED AND SENT TO THE OFFICE. THE SCRUB TECHNIQUE MADE ME AWARE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9672567 ↗
• MalfunctionJan 23, 2020Device-Device Incompatibility; Device-Device Incompatibility

  SUMMIT REAMERS WERE NOT PROPERLY ENGAGING INTO THE ADAPTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9619768 ↗
• MalfunctionOct 30, 2019Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut

  IT WAS REPORTED THAT THE SUMMIT SZ0/1, 2/3, 4/5, 6/7, 8/9 TAPERED REAMER ARE ALL DULL. NEEDS REPLACEMENT X'S 4.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9257716 ↗
• MalfunctionOct 30, 2019Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut

  IT WAS REPORTED THAT THE SUMMIT SZ0/1, 2/3, 4/5, 6/7, 8/9 TAPERED REAMER ARE ALL DULL. NEEDS REPLACEMENT X'S 4.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9257714 ↗
• MalfunctionOct 30, 2019Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut

  IT WAS REPORTED THAT THE SUMMIT SZ0/1, 2/3, 4/5, 6/7, 8/9 TAPERED REAMER ARE ALL DULL. NEEDS REPLACEMENT X'S 4.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9257713 ↗
• MalfunctionOct 30, 2019Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut

  IT WAS REPORTED THAT THE SUMMIT SZ0/1, 2/3, 4/5, 6/7, 8/9 TAPERED REAMER ARE ALL DULL. NEEDS REPLACEMENT X'S 4.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9257711 ↗
• MalfunctionJul 15, 2019Dull, Blunt; Dull, Blunt

  THE SUMMIT TAPERED REAMERS NEED REPLACEMENTS. THE SURGEON FEELS THAT THEY AREN¿T SHARP ENOUGH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8790256 ↗
• MalfunctionJul 15, 2019Dull, Blunt; Dull, Blunt

  THE SUMMIT TAPERED REAMERS NEED REPLACEMENTS. THE SURGEON FEELS THAT THEY AREN¿T SHARP ENOUGH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8790226 ↗
• MalfunctionJul 15, 2019Dull, Blunt; Dull, Blunt

  THE SUMMIT TAPERED REAMERS NEED REPLACEMENTS. THE SURGEON FEELS THAT THEY AREN¿T SHARP ENOUGH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8790224 ↗
• MalfunctionDec 4, 2018Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE SURGEON WENT TO REAM THE FEMORAL CANAL AND THE REAMERS DID NOT CATCH IN THE HUDSON ADAPTER. THE HUDSON ADAPTER WAS SPINNING AND THE REAMERS WERE NOT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8128921 ↗