SUMMIT 2570-02-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295143048), received between Jan 11, 2019 and Oct 30, 2024 — classified as 7 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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE HOSPITAL STAFF THREW THE BIPOLAR RETAINING CLIP IN THE TRASH, THINKING THAT IT WAS A DISPOSABLE INSTRUMENT. THE SUMMIT REAMERS HAVE ALSO BECOME DULL. THIS DID NOT DELAY SURGERY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20566006 ↗
• MalfunctionOct 11, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED ON (B)(6) 2024 THAT THE HOSPITAL STAFF DROPPED THE BIPOLAR RETAINING CLIP. THE SUMMIT REAMERS HAVE BECOME DULL. THIS DID NOT DELAY SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 20432440 ↗
• MalfunctionOct 11, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20431774 ↗
• MalfunctionOct 11, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20431749 ↗
• MalfunctionMar 23, 2020Dull, Blunt; Material Twisted/Bent; Illegible Information; Dull, Blunt; 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 9867861 ↗
• MalfunctionMar 23, 2020Dull, Blunt; Material Twisted/Bent; Illegible Information; Dull, Blunt; 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 9867846 ↗
• MalfunctionJan 11, 2019Device-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 8240200 ↗