SUMMIT 2570-05-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 225 adverse event reports that list this exact device (DI 10603295143215), received between Sep 1, 2017 and Sep 15, 2026 — classified as 225 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (105 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 25 most recent of 225 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779052 ↗
• MalfunctionMay 4, 2026Material Deformation

  IT WAS REPORTED THAT THE T-HANDLES HAVE A LARGE CRACK IN THE MIDDLE AND CANNOT BE STERILIZED. THE SUMMIT STANDARD STEM INSERTER HAS A DEFORMED TIP AND CANNOT BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25067590 ↗
• MalfunctionFeb 20, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THE INSTRUMENT HAS A BLUNTED TIP; GETS STUCK INSIDE STEM AND MUST BE FORCIBLY REMOVED. NO PATIENT OUTCOMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400385 ↗
• MalfunctionDec 26, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THERE WAS NO ADVERSE EVENTS, LOT NUMBERS NOT VISIBLE. THE ITEMS HAVE BEEN DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23899472 ↗
• MalfunctionDec 26, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: NO ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23899381 ↗
• MalfunctionDec 26, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT NO ADVERSE EVENTS, LOT NUMBERS NOT VISIBLE. THE ITEMS HAVE BEEN DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23899333 ↗
• MalfunctionDec 26, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT NO ADVERSE EVENTS, LOT NUMBERS NOT VISIBLE. THE ITEMS HAVE BEEN DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23899279 ↗
• MalfunctionDec 26, 2025Device-Device Incompatibility; Device-Device Incompatibility

  THE METALL IS WORN, SO THE FEMURCOMPONENT CAN NOT BE STABILE INSERTER TO THE FEMURCANAL WITH THE INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23897698 ↗
• MalfunctionDec 22, 2025Break; Break

  IT WAS REPORTED THAT (3) BROKEN IMPACTOR INSERTERS. THE DEVICES WERE BLUNT AND BROKEN. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864462 ↗
• MalfunctionDec 22, 2025Break; Break

  IT WAS REPORTED THAT (3) BROKEN IMPACTOR INSERTERS. THE DEVICES WERE BLUNT AND BROKEN. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864450 ↗
• MalfunctionDec 22, 2025Break; Break

  IT WAS REPORTED THAT (3) BROKEN IMPACTOR INSERTERS. THE DEVICES WERE BLUNT AND BROKEN. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864449 ↗
• MalfunctionDec 16, 2025Device-Device Incompatibility; Material Deformation; Material Integrity Problem; Device-Device Incompatibility; Material Deformation; Material Integrity Problem

  ADDITIONAL INFORMATION RECEIVED: A. CAN YOU PLEASE CLARIFY WHAT DO YOU MEAN BY "DAMAGED"? WAS IT WORN, CRACKED, BROKEN INTO PIECES, BENT, STRIPPED, CROSS THREADED OR ANY DEVICE INTERACTION? RESPONSE: IT WAS WORN/DEFORMED AT THE TIP MEANING IT DOES NOT ENGAGE PROPERLY INTO THE IMPLANT. IT IS GENERAL WEAR AND TEAR AND HAPPEN FREQUENTLY WITH THIS INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821110 ↗
• MalfunctionDec 11, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CORAIL STEM COULD NOT FIT ONTO THE HANDLE. IT WAS REPORTED THAT AT THE POINT OF CONTACT, THE METAL SITE HAD CHANGED SHAPE. IT WAS REPORTED THAT THERE WAS NO ALLEGATION AGAINST THE CORAIL STEM DEVICE. IT WAS FURTHER OBSERVED THAT THE METAL RING ON TOP OF THE PINNACLE INSERTER HANDLE HAD SNAPPED OFF. IT WAS REPORTED THAT A NEW DEVICE WAS OPENED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, OR SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778172 ↗
• MalfunctionNov 12, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT IS DAMAGED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533822 ↗
• MalfunctionOct 27, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE IMPACTOR TIP WAS DAMAGED DUE TO WEAR AND TEAR, GETS STUCK IN IMPLANT WHEN FINISHED IMPACTING. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390308 ↗
• MalfunctionOct 15, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT A SINGLE PIECE CORAIL STEM INSERTER INSTRUMENT WAS FAULTY. UNABLE TO THREAD INTO STEM IMPLANT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. UPON VISUAL INSPECTION, A SECOND INSERTER WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294615 ↗
• MalfunctionSep 9, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT A CORAIL STEM INTRODUCER NEEDS REPLACING AS WHERE IT ENGAGES WITH THE STEM IT LOCKS THE STEM IN PLACE AND IT IS HARD TO REMOVE. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23008515 ↗
• MalfunctionJul 30, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE END OF THE INSERTER IS BENT. THERE WAS NO HARM TO PATIENT AND NO DELAY TO SURGERY OCCURRED AS A RESULT. THE ISSUE WAS FOUND DURING ROUTINE INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22664170 ↗
• MalfunctionJun 26, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE ITEM HAD A BENT TIP AND WAS STUCK IN THE IMPLANT. THERE WAS NO PATIENT CONSEQUENCE. THE INSTRUMENT WAS SUCCESSFULLY RETRIEVED FROM THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22335258 ↗
• MalfunctionJun 23, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT A SUMMIT STEM INSERTER HAS A DAMAGED/WARPED TIP AND GETS STUCK IN IMPLANT WHEN IMPACTING. T HANDLE HAS A CRACK IN IT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309103 ↗
• MalfunctionJun 19, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE SINGLE PIECE CORAIL STEM INSERTER INSTRUMENT IS FAULTY. IT IS UNABLE TO THREAD INTO STEM IMPLANT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293535 ↗
• MalfunctionJun 11, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE INSTRUMENT IS BURRED AND DOES NOT ENGAGE WITH PROSTHESIS PROPERLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22186292 ↗
• MalfunctionMay 20, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE HE INSTRUMENT CORAIL AMT NECK SEG 135D STD AND BROACH CORAIL SIZE 14, GOT STUCK TOGETHER WHEN TRIALING AND CANNOT BE SEPARATED. THE INSTRUMENTS SUMMIT STANDARD IMP. INSERTER AND QUICKSET TAPER HEX SCDR RIGID HAS A WORN OUT THREADS/TIP WHICH TENDS FOR THE IMPLANT TO GET STUCK AS WELL. ANOTHER SET WAS OPENED TO USE. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO ADDITIONAL TIME REQUIRED ONLY WAS WHEN OPENING FOR ANOTHER SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22054865 ↗
• MalfunctionMay 1, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  DURING ROUTINE MAINTENANCE IT WAS DISCOVERED THAT TWO STANDARD IMPACTORS WERE DAMAGED DUE TO REGULAR USE. THE TIP WHICH CONNECTS TO THE STEM IS WORN AND FEELS LOOSE WHEN THE STEM IS BEING INSERTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942678 ↗
• MalfunctionMay 1, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT DURING ROUTINE MAINTENANCE IT WAS DISCOVERED THAT TWO STANDARD IMPACTORS WERE DAMAGED DUE TO REGULAR USE. THE TIP WHICH CONNECTS TO THE STEM IS WORN AND FEELS LOOSE WHEN THE STEM IS BEING INSERTED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942657 ↗