SUMMIT 2570-00-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295142850), received between Mar 22, 2018 and Jul 2, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2025Break; Break

  IT WAS REPORTED THAT THE WELDING ON THREADED SUMMIT INSERTER BROKE. ALL PIECES WERE RETRIEVED. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384373 ↗
• MalfunctionApr 19, 2022Break; Break

  IT WAS REPORTED THAT THE SURGEON PERFORMED A TOTAL HIP ON THIS PATIENT. WHILE EXTRACTING THE FEMORAL BROACH THE BROACH EXTRACTING HANDLE TIP BROKE OFF. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141169 ↗
• MalfunctionJan 28, 2022Break; Break

  IT WAS REPORTED THAT WHILE ATTEMPTING TO EXTRACT A SUMMIT BROACH, THE SUMMIT EXTRACTOR HANDLE BROKE. BOTH THE TIP AND THE HANDLE WERE COLLECTED AND DECONTAMINATED AND READY FOR RETURN. A REPLACEMENT HANDLE IS NEEDED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13385245 ↗
• MalfunctionMay 5, 2021Break; Break

  IT WAS REPORTED THAT WHILE REMOVING A SUMMIT BROACH THE TIP OF THE EXTRACTION HANDLE BROKE OFF. BOTH PIECES WERE COLLECTED, AND DECONTAMINATED FOR RETURN. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11777414 ↗
• MalfunctionDec 4, 2020Material Twisted/Bent; Material Twisted/Bent

  DURING A HEMI HIP AT (B)(6) ROUGHLY AROUND 1500, WE NEEDED TO REMOVE A SUMMIT PRESSFIT STEM FROM A FEMORAL CANAL. WE GRABBED THE THREADED STEM IN (B)(6). WE ATTEMPTED TO THREAD THE STEM INSERTER INTO THE STEM AND NOTICED THAT IT WAS BARELY GRIPPING OPPOSING THREADS WITH GREAT DIFFICULTY. UPON INSPECTION WE NOTICED THE THREADS ON THE TIP OF THE INSERTER WERE ¿STRIPPED¿. DESPITE THIS, WE WERE ABLE TO REMOVE THE STEM FROM THE FEMORAL CANAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10944522 ↗
• MalfunctionAug 4, 2020Break; Break

  IT WAS REPORTED THAT THE SURGEON WAS ATTEMPTING TO UTILIZE THE SUMMIT BROACH EXTRACTOR, THE TIP OF THE EXTRACTOR BROKE OFF. ALL THE PIECES WERE COLLECTED, DECONTAMINATED, AND WILL BE RETURNED. A REPLACEMENT HANDLE WAS NEEDED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10364379 ↗
• MalfunctionAug 3, 2020Break; Break

  IT WAS REPORTED THAT THE SURGEON WAS REMOVING A SUMMIT BROACH, THE TIP OF THE EXTRACTOR WAS BROKEN OFF. ALL THE PIECES WERE COLLECTED, DECONTAMINATED AND WILL BE RETURNED. A REPLACEMENT EXTRACTOR WAS NEEDED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10360117 ↗
• MalfunctionMar 26, 2020Break; Break

  IT WAS REPORTED THAT WHILE THE SURGEON WAS REMOVING A SUMMIT BROACH, THE TIP OF THE EXTRACTOR HANDLE BROKE OFF. BOTH PIECES WERE COLLECTED, DECONTAMINATED AND PREPARED FOR RETURN. A REPLACEMENT INST IS NEEDED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9884930 ↗
• MalfunctionOct 1, 2019Device-Device Incompatibility; Device-Device Incompatibility

  C-STEM PINNACLE THR: (B)(6) 2019. WHEN THEY WERE BROACHING TO PREPARE THE FEMUR, THE SCRUB NURSE NOTICED THAT THE END OF THE BROACH HANDLE WAS DAMAGED. WHEN THE SURGEON IS REMOVING THE BROACH HANDLE WITH THE MALLET AS PER THE SURGICAL TECHNIQUE, THEY COULD SEE THE END OF THE BROACH HANDLE DETACHING FROM THE MAIN UNIT. THEY THEN HAD TO OPEN THE LOAN SET ON SITE TO USE THAT BROACH HANDLE IN ORDER TO COMPLETE THE PROCEDURE. THIS ADDED A MINOR DELAY OF +/- 5MINS WHILE WE OPENED THE SET. DESIRED OUTCOME WAS ACHIEVED. FEMALE PATIENT, APPROXIMATELY (B)(6).

  Patient problems: Not Applicable

  MAUDE report 9140299 ↗
• MalfunctionJul 2, 2019Break; Break

  IT WAS REPORTED THAT WHILE EXTRACTING THE SUMMIT BROACH, THE TIP OF THE EXTRACTOR BROKE OFF. THE PIECES WERE COLLECTED, DECONTAMINATED AND WILL BE RETURNED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8754455 ↗
• MalfunctionMay 23, 2019Break; Break

  IT WAS REPORTED THAT WHILE EXTRACTING A SUMMIT BROACH THE HANDLE BROKE. THE LITTLE TIP BROKE OFF. THE PIECES WERE COLLECTED AND DECONTAMINATED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8638088 ↗
• MalfunctionApr 4, 2019Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT THE BROACH EXTRACTOR TIP BROKE OFF WHILE THE DR. WAS TRYING TO REMOVE A BROACH. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8483119 ↗
• MalfunctionMar 27, 2019Break; Material Discolored; Break; Material Discolored

  IT WAS REPORTED THAT WHILE PUTTING AWAY INSTRUMENT SETS TODAY, I FOUND SOME WAS BROKEN INSTRUMENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8457903 ↗
• MalfunctionNov 30, 2018Break; Break

  IT WAS REPORTED THAT WHILE EXTRACTING THE SUMMIT BROACH THE TIP OF THE EXTRACTOR HANDLE BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8119694 ↗
• MalfunctionSep 7, 2018Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT WHILE THE SALES REP WAS PUTTING THE SUMMIT CORE SET TOGETHER, HE NOTICED A BROKEN EXTRACTOR HANDLE. THE TIP BROKE OFF AND WAS MISSING. IT WAS UNCLEAR WHEN THE TIP BROKE AND THE TIP WAS NOT LOCATED. ALL THE OTHER SETS HAVE BEEN CHECKED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7854784 ↗
• MalfunctionApr 10, 2018Break; Break

  IT WAS REPORTED THAT WHILE EXTRACTING THE SUMMIT BROACH FROM THE PATIENT, THE TIP OF THE EXTRACTOR BROKE OFF. THE TIP WAS RECOVERED, CHECKED TO BE COMPLETE AND DECONTAMINATED FOR RETURN. A REPLACEMENT PART IS NEEDED. NO SURGICAL DELAY. ALL PIECES RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7412480 ↗
• MalfunctionApr 10, 2018Break; Break

  IT WAS REPORTED THAT WHILE EXTRACTING THE SUMMIT BROACH FROM THE PATIENT, THE TIP OF THE EXTRACTOR BROKE OFF. THE TIP WAS RECOVERED, CHECKED TO BE COMPLETE AND DECONTAMINATED FOR RETURN. A REPLACEMENT PART IS NEEDED. NO SURGICAL DELAY. ALL PIECES RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7412422 ↗
• MalfunctionMar 22, 2018Break; Break

  IT WAS REPORTED THAT WHILE SURGEON WAS EXTRACTING A SUMMIT HIP STEM BROACH, THE TIP OF THE EXTRACTOR BROKE OFF. THE TIP WAS FOUND AND COLLECTED AND MATCHED UP. ALL THE PIECES WERE THERE AND COMPLETE. THEY WERE STERILIZED AND WILL BE RETURNED. A REPLACEMENT IS NEEDED. NO SURGICAL DELAY. ALL PIECES RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7361152 ↗