SUMMIT 2570-00-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295142911), received between Nov 9, 2017 and Sep 13, 2024 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (9 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.

• MalfunctionSep 13, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT UPON INSPECTION THE FOLLOWING PARTS WERE FOUND. SUMMIT BROACH SZ4 - NOT ATTACHING TO BROACH HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20215181 ↗
• MalfunctionAug 20, 2024Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT THE TIP OF THE BROACH HAD A SCUFF MARK THAT PREVENTED IT FROM FITTING INTO THE BROACH HANDLE.

  Patient problems: Insufficient Information

  MAUDE report 20005102 ↗
• MalfunctionAug 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE METAL HAD SUBSIDED INTO THE SLOT WHERE A TRIAL NECK SITS NOT ALLOWING IT TO SEAT PROPERLY.

  Patient problems: Insufficient Information

  MAUDE report 19959427 ↗
• MalfunctionNov 14, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE NIPPLE ON THE BROACH WAS BROKEN OFF, COULD NOT ATTACH BROACH TO BROACH HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18133338 ↗
• MalfunctionMay 2, 2023Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE CONNECTION POINT ON THE BROACH WAS DEFECTIVE AND WOULD NOT CONNECT TO THE BROACH HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16853120 ↗
• MalfunctionApr 10, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT WHEN LOADING THE SIZE 4 SUMMIT BROACH, THE SCRUB TECH AND SURGEON HAD SIGNIFICANT DIFFICULTY LATCHING AND REMOVING THE BROACH FROM MULTIPLE ATTACHMENTS. FOLLOWING THE SURGERY, IT WAS DETERMINED THAT THE MALE END OF THE BROACH ATTACHMENT IS BENT AND IS CAUSING THE BROACH TO STICK IN ALL BROACH HANDLES AND KINCISE ATTACHMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16706711 ↗
• MalfunctionNov 10, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE WHITE PLASTIC HANDLE ARE CRACKED, THE STRIKE PLATE OF THE IMPACTOR IS BROKEN, THE RASP IS LOOSE WHEN SECURED ON IT, THE INNER PART IS DAMAGE PREVENTING THE NECK TO SIT PROPERLY, AND THE RING GRABS THE HEAD TRIALS TO TIGHT. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15777530 ↗
• MalfunctionJul 6, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BROACH HANDLE DIFFICULTY ATTACHING TO BROACH. NECK SEGMENT WAS DIFFICULT TO ASSEMBLE. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14934410 ↗
• MalfunctionFeb 23, 2022Device-Device Incompatibility; Device-Device Incompatibility

  BROACH STICKS TO BROACH HANDLE. GUIDE IS BROKEN. ALL PIECES WERE RETRIEVED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13586559 ↗
• MalfunctionMar 22, 2021Material Twisted/Bent; Illegible Information; Material Twisted/Bent; Illegible Information

  IT WAS REPORTED THAT THE BROACHES WERE WORN FROM NORMAL USE THEY WERE NOT REMOVING ENOUGH BONE THEN CAUSING THE IMPLANT TO SIT PROUD A BIT. SURGERY WASN¿T DELAYED AND NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11541723 ↗
• MalfunctionMar 22, 2021Material Twisted/Bent; Illegible Information; Material Twisted/Bent; Illegible Information

  IT WAS REPORTED THAT THE BROACHES WERE WORN FROM NORMAL USE THEY WERE NOT REMOVING ENOUGH BONE THEN CAUSING THE IMPLANT TO SIT PROUD A BIT. SURGERY WASN¿T DELAYED AND NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11541676 ↗
• MalfunctionDec 29, 2020Material Integrity Problem; Material Integrity Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020 VIA THA. IT WAS REPORTED THAT DURING THE SURGERY, THE SURGEON FELT SOMETHING'S WRONG ABOUT MOVING WHEN USING THE BROACH WITH THE CALCAR REAMER. THE SURGERY WAS COMPLETED WITHIN 30 MINUTES DELAY. AFTER THE SURGERY, THE NEXT DAY, THE STAFF CHECKED THE DEVICES AND FOUND THAT THERE WERE SOME DAMAGE ON THE BROACH AND THE HOLE OF THE CALCAR REAMER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 11087422 ↗
• 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 9867975 ↗
• 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 9867963 ↗
• MalfunctionOct 25, 2019Material Twisted/Bent; Material Twisted/Bent

  POST IS BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9241519 ↗
• MalfunctionJul 27, 2018Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE SIZE 4 BROACH AND HANDLE WERE NOT FUNCTIONING PROPERLY. THE BROACH HANDLE WOULD NOT LOCK TO ANY BROACH HANDLE AND THE SIZE 4 BROACH COULD NOT BE USED WITH ANY BROACH HANDLE. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7726451 ↗
• MalfunctionNov 9, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SIZE 4 SUMMIT BROACH IS DAMAGED AND GETS STUCK ON THE BROACH HANDLE CAUSING A DELAY IN THE CASE.

  Patient problems: No Information

  MAUDE report 7014094 ↗