SUMMIT 2570-00-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295142959), received between Feb 23, 2018 and Nov 21, 2023 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2023Break; Break

  IT WAS REPORTED THAT THE POST ON SIZE 8 BROACH BROKE IN HALF WHILE BROACHING WITH KINCISE. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 18181077 ↗
• MalfunctionSep 30, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT WHILE REMOVING THE SUMMIT BROACH FROM THE FEMORAL CANAL, THE BROACH ATTACHMENT POST BECAME BENT. THIS MAKES THE BROACH UNABLE TO ATTACH TO THE BROACH HANDLE. ALL PARTS RETURNING. SURGERY WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15509397 ↗
• InjuryNov 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING BROACHING PROXIMAL FEMUR CRACKED. CERCLAGE WIRE WAS PLACED, CASE COMPLETED SUCCESSFULLY. DOI: UNKNOWN, DOR: (B)(6) 2021, UNKNOWN SIDE.

  Patient problems: Bone Fracture(s)

  MAUDE report 12752556 ↗
• 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 9867994 ↗
• 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 9867987 ↗
• InjuryOct 18, 2019Break; Break

  IT WAS REPORTED THAT THE BROKEN INSTRUMENTATION REQUIRING OSTEOTOMY. PATIENT WAS BROUGHT TO THE OPERATING ROOM FOR A LEFT ANTERIOR TOTAL HIP REPLACEMENT. DURING THE PROCEDURE, THERE WAS MALFUNCTION OF THE DEPUY FEMORAL TRIAL BROACH (FRACTURE OF THE BROACH) WHICH REQUIRED OSTEOMY OF THE FEMUR FOR THE REMOVAL OF THE TRIAL BROACH.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9209054 ↗
• InjuryMar 18, 2019Break; Break

  SIZE 8 SUMMIT BROACH BECAME INCARCERATED IN FEMUR DURING DAA THR. SIZE 8 SUMMIT BROACH EXTRACTION TRUNION BROKE WHILE ATTEMPTING THE EXTRACT BROACH. SURGERY WAS DELAYED OF 180 MINUTES. FEMORAL OSTEOTOMY TO EXTRACT BROACH WAS PERFORMED WHEN EVENT OCCURRED TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WERE FRAGMENTS GENERATED BUT WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION.

  Patient problems: Not Applicable

  MAUDE report 8429881 ↗
• MalfunctionFeb 23, 2018Break; Break

  IT WAS REPORTED THAT DURING BROACHING OF THE FEMUR THE MALE END OF THE BROACH BROKE OFF IN THE BROACH HANDLE. ALL PIECES WERE RETRIEVED. SURGICAL DELAY OF 10 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7291956 ↗