SUMMIT 2570-00-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295142928), received between Sep 22, 2017 and Feb 21, 2023 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2023Break; Break

  WHILE DOING A TOTAL HIP USING A SUMMIT STEM, THE SIZE 5 SUMMIT BROACH BROKE WHERE IT INSERTS INTO THE BROACH HANDLE. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16409098 ↗
• MalfunctionNov 21, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS BROACHED TO A SIZE 5 SUMMIT, WHICH WAS STABLE. WHILE INSERTING STEM IMPLANT DID NOT MATCH STABILITY, SUBSIDED. NO COMPLICATIONS OCCURRED, SURGEON OPTED TO GO TO A SIZE 6 FEMORAL IMPLANT. THERE WAS 5 MINS OF SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15835654 ↗
• MalfunctionJul 5, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT 5 BROACH WOULD NOT GO INTO THE BROACH HANDLE COMPLETELY. THE SURGEON CHOSE TO MOVE FORWARD WITH SEQUENTIAL BROACH TO THE NEXT SIZE WITHOUT ISSUE. UPON INSPECTION AFTER DECONTAMINATION, THERE APPEARS TO BE SOME DAMAGE TO THE PLACE WHERE THE BROACH HANDLE CONNECTS TO THE BROACH. IT LOOKS LIKE A BURR OF SOME SORT THAT RESTRICTS THE BROACH HANDLE FROM SEATING. THERE WAS A SURGICAL DELAY OF 45 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14914974 ↗
• MalfunctionJun 7, 2021Break; Break

  IMPACTING THE SUMMIT FEMORAL BROACH SIZE 5 (FROM THE CONSIGNED SET) INTO THE PATIENTS FEMUR AND THE TRUNION/NECK BROKE OFF THE BROACH IN THE BROACH IMPACTOR HANDLE. NO SURGERY DELAY. PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11947909 ↗
• 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 11541739 ↗
• 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 11541646 ↗
• MalfunctionNov 19, 2020Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  SIZE 5 SUMMIT BROACH WOULD NOT CONNECT PROPERLY TO BROACH HANDLE DUE TO DAMAGED CONNECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10871618 ↗
• MalfunctionAug 4, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE POST BROKE OFF THE SZ6 BROACH AND THE SZ 5 IS BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10364637 ↗
• 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 9867952 ↗
• 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 9867944 ↗
• MalfunctionFeb 26, 2020Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  BROACH WAS STUCK IN THE KINCISE BROACH HANDLE. HAD TO FORCE IT OFF AND FINISH WITH A REGULAR BROACH HANDLE. THERE WAS A SURGICAL DELAY OF 2 MINUTES.

  Patient problems: No Code Available

  MAUDE report 9759043 ↗
• MalfunctionFeb 6, 2020Break; Break

  IT WAS REPORTED THAT THE SURGEON WAS TAKING OUT THE BROACH WITH KINCISE IMPACTOR. THE ATTACHMENT WAS LOCKED AND ATTACHED CORRECTLY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9678018 ↗
• MalfunctionDec 12, 2018Break; Break

  IT WAS REPORTED THAT THE SPINE ON BROACH BROKE OFF WHILE REMOVING BROACH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8155535 ↗
• MalfunctionJun 20, 2018Break; Break

  IT WAS REPORTED THAT THE SPINE ON THE BROACH BROKE OFF ON THE BROACH HANDLE. ALL PIECES WERE RETRIEVED AND THE SURGERY WAS NOT DELAYED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7621221 ↗
• MalfunctionOct 18, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SIZE 5 SUMMIT BROACH WOULD NOT ALLOW TRIAL NECK TO SEAT PROPERLY. DID NOT DELAY SURGERY.

  Patient problems: No Information

  MAUDE report 6959619 ↗
• MalfunctionSep 22, 2017Break; Break

  IT WAS REPORTED THAT FOLLOWING A TOTAL HIP CASE HE WAS PUTTING INSTRUMENTS BACK IN PANS AND NOTICED THE SIZE 5 SUMMIT HIP BROACH WAS BROKEN. THE LOCKING STUB FOR THE BROACH HANDLE WAS SNAPPED OFF. NOTHING WAS MENTIONED ABOUT IT IN THE CASE SO HE ASSUME THAT IT WAS WEAKENED FROM YEARS OF USE AND BROKE DURING HANDLING IN SPD.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 6885921 ↗