SUMMIT 2570-00-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10603295142867), received between Sep 19, 2018 and Oct 29, 2024 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (17 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 25 most recent of 30 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 20556539 ↗
• 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 20429763 ↗
• 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 20429592 ↗
• 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 20429552 ↗
• MalfunctionOct 20, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A BHA. DURING SURGERY, THE T-HANDLE IN QUESTION AND A REAMER DID NOT MATCH, SO THE T-HANDLE IN QUESTION COULD NOT BE USED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17974305 ↗
• MalfunctionAug 25, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT A SUMMIT LATERALIZER WILL NO LONGER ATTACH TO THE CHUCK ATTACHMENT AND IS NO LONGER USABLE DUE TO WEAR AND TEAR. THIS OCCURRED INTRA OP BUT SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAYS OR PATIENT ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17627817 ↗
• MalfunctionSep 14, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE LATERALIZER IS DULL. THERE WAS A 10 MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15419076 ↗
• MalfunctionAug 3, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE LATERALIZER IS DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15157018 ↗
• MalfunctionJan 14, 2022Failure to Cut; Failure to Cut

  INSTRUMENT IS DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13260417 ↗
• MalfunctionJan 14, 2022Failure to Cut; Failure to Cut

  INSTRUMENTS ARE DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13258839 ↗
• MalfunctionJan 14, 2022Failure to Cut; Failure to Cut

  INSTRUMENTS ARE DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13258837 ↗
• MalfunctionDec 17, 2021Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn

  LATERALIZER REAMER FROM TWO SUMMIT TRAYS WERE DULL. THERE WERE KICKS AND BURR MARKS ON TWO BROACH HANDLE ALIGNMENT RODS. NO SURGICAL DELAY OR ADVERSE AFFECT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13026482 ↗
• MalfunctionDec 17, 2021Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn

  LATERALIZER REAMER FROM TWO SUMMIT TRAYS WERE DULL. THERE WERE KICKS AND BURR MARKS ON TWO BROACH HANDLE ALIGNMENT RODS. NO SURGICAL DELAY OR ADVERSE AFFECT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13026479 ↗
• MalfunctionDec 7, 2021Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn

  IT WAS REPORTED THAT THE INSTRUMENT IS BLUNT AND WORN DUE TO USAGE. SECOND KIT WAS OPENED SO THE SURGERY WAS CONTINUED. THERE WAS A THREE MINUTE SURGICAL DELAY. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12950782 ↗
• MalfunctionMay 10, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE REAMER IS DULL AND NEEDS REPLACEMENT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797707 ↗
• MalfunctionMay 10, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE REAMER IS DULL AND NEEDS TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797626 ↗
• MalfunctionJan 22, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT REAMER IS DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11214593 ↗
• MalfunctionAug 26, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE HUDSON CONNECTION ON REAMER WAS WORN. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10456582 ↗
• 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 9859627 ↗
• 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 9859626 ↗
• 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 9672564 ↗
• 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 8790257 ↗
• 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 8790255 ↗
• 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 8790254 ↗
• MalfunctionMay 17, 2019Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE LATERALIZING REAMER IS DULL, MAKING THE REMOVING OF BONE DIFFICULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8619355 ↗