SUMMIT 2570-00-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295142935), received between Oct 3, 2017 and Aug 28, 2025 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2025Break; Break

  IT WAS REPORTED THAT THE SIZE 6 SUMMIT TRIAL BROACH BROKEN AFTER SURGERY. IT COULD NOT BE USED AS IT WAS BROKEN INTO TWO PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22914171 ↗
• MalfunctionJun 30, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE DEVICE (ARTIC/EZE TR BALL GRVD 32+1 ;253091000) WAS FOUND DURING THE VISUAL EXAMINATION PERFORMED ON 07-18-2025 THAT IT IS CONDITION: SCRATCHES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22359901 ↗
• MalfunctionJun 13, 2025Break; Break

  IT WAS REPORTED THAT AS THE DOCTOR WAS IMPACTING THE 6 BROACH, THE NUB BROKE OFF THE BROACH AND SURGEON HAD TROUBLE REMOVING SAID BROACH. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. FRAGMENTS WERE GENERATED AND WERE EASILY REMOVED WITHOUT REQUIRING ADDITIONAL INTERVENTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203941 ↗
• MalfunctionJan 25, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT SIZE 6 BROACH GOT CAUGHT IN BROACH HANDLES. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 16244251 ↗
• MalfunctionApr 19, 2022Break; Break

  THE KNOB ON THE SIZE 6 SUMMIT BROACH BROKE WHILE CALCAR PLANING. SURGICAL DELAY OF 5 MINUTES OCCURRED.

  Patient problems: Insufficient Information

  MAUDE report 14140990 ↗
• MalfunctionFeb 11, 2022Break; Break

  IT WAS REPORTED THAT THE METAL FLAKES WERE COMING OFF BROACH WHEN CALCAR REAMING. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13515152 ↗
• MalfunctionDec 16, 2021Device-Device Incompatibility; Device-Device Incompatibility

  THE 30MM FLEXIBLE DRILL BITS WERE BROKEN WHILE DRILLING HOLES IN ACETABULAR CUP FOR SCREW PLACEMENT, NO DELAY IN SURGERY. WHILE ATTEMPTING TO PLACE BROACH ON BROACH HANDLE THE TRUNNION ON THE BROACH WOULDN¿T SEAT ON HANDLE, NOT ALLOWING HANDLE TO ENGAGE TO LOCK BROACH INTO PLACE. NO DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13022003 ↗
• MalfunctionOct 1, 2021Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE BROKEN PIECE WAS REMOVED FROM THE BROACH HANDLE. THERE WAS NO REPORTED ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 12563382 ↗
• MalfunctionJun 9, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE MALE CONNECTION PART ON THE SUMMIT SIZE 6 BROACH BROKE DURING SURGEON USE. THE BROKEN TIP WAS NO LONGER THAN 10MM AND WAS FOUND INSIDE THE BROACH HANDLE. ALL PARTS WERE HELD TOGETHER TO ENSURE THERE WERE NOT ANY REMAINING PIECES. WAS VERIFIED BY SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11968382 ↗
• 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 11541737 ↗
• 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 11541657 ↗
• MalfunctionFeb 10, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT IT WAS DIFFICULT TO GET THE SUMMIT SIZE 6 BROACH SEATED ONTO THE BROACH HANDLE, THERE WAS NO DELAY IN THE CASE AND NO PIECES WHERE BROKEN. AFTER THE CASE AND INSPECTION, IT WAS NOTICED THAT THE POST WAS SLIGHTLY BENT AND VERY DIFFICULT TO SEAT ON THE HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11310446 ↗
• MalfunctionNov 19, 2020Break; Break

  IT WAS REPORTED THAT THE NECK ON THE BROACH WHERE THE BROACH HANDLE ATTACHES BROKE DURING THE CASE. SURGICAL DELAY OF 3-4 MINUTES.

  Patient problems: No Code Available

  MAUDE report 10870087 ↗
• MalfunctionAug 4, 2020Break; Break

  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 10364636 ↗
• MalfunctionJul 7, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE STEM ON SIZE 6 SUMMIT BROACH WAS BENT WHILE TRYING TO EXTRACT THE BROACH FROM THE PATIENT. IT IS BENT TO THE POINT THAT IT CANNOT ATTACH TO THE BROACH HANDLE APPROPRIATELY. THE BROACH HAS BEEN USED IN OVER 200 SURGERIES. THE BROACH WAS HARD TO EXTRACT SO THE TIME OF THE SURGERY WAS EXTENDED BY 30 MINUTES WHILE THE SURGEON TRIED TO EXTRACT THE BROACH.

  Patient problems: No Code Available

  MAUDE report 10240017 ↗
• MalfunctionMar 30, 2020Break; Break

  IT WAS REPORTED THAT THE TIP ON BROACH BROKE OFF IN HANDLE. ALL PIECES RETRIEVED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9898355 ↗
• 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 9867978 ↗
• 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 9867949 ↗
• MalfunctionJan 24, 2020Break; Break

  POST ON SUMMIT SIZE 6 BROACH BROKE OFF DURING USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9628947 ↗
• MalfunctionOct 22, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS HAVING A RIGHT TOTAL HIP WITH THE ANTERIOR APPROACH. DURING BROACHING OF THE FEMUR, THE MALE END OF THE SUMMIT BROACH BROKE OFF. ALL PIECES WERE FOUND. THE SURGEON USES THE DOUBLE OFFSET BROACH HANDLES. THERE WAS 5 MINUTES SURGICAL DELAY.

  Patient problems: Not Applicable

  MAUDE report 9219414 ↗
• MalfunctionOct 20, 2017Break; Break

  IT WAS REPORTED THAT THE TRUNNION SIZE 6 SUMMIT BROACH BROKE POST-OPERATIVELY.

  Patient problems: No Information

  MAUDE report 6965679 ↗
• MalfunctionOct 3, 2017Break; Break

  IT WAS REPORTED A DAMAGED CUTTING TEETH ON MEDICAL SUPERIOR SURFACE. AUGUST 10, 2017 - REVIEW OF PROVIDED PHOTOGRAPH ALSO FOUND DEEP CIRCULAR SCRATCHING ON THE TAPER. (B)(6). OCTOBER 3, 2017 - EVALUATION OF THE RETURNED INSTRUMENT FOUND PIECES OF MATERIAL MISSING FROM THE DAMAGED TEETH. (B)(6).

  Patient problems: No Information

  MAUDE report 6911752 ↗