SUMMIT 2570-05-125Recalls & reported problems
Depuy Orthopaedics, Inc. · SUMMIT ANGLED INSERTER · Class 1
All models of SUMMIT (53)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295143222), received between Sep 8, 2017 and May 12, 2026 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Break” (8 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break8
- Device-Device Incompatibility3
- Material Deformation3
- Naturally Worn1
- No Apparent Adverse Event1
Patient problems
- No Consequences Or Impact To Patient8
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information1
- Limb Fracture1
- No Information1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 12, 2026No Apparent Adverse Event
IT WAS REPORTED THAT INSTRUMENT HAD UNKNOWN ALLEGATION IT DID NOT HAPPEN IN SURGERY. INVESTIGATION DETERMINED THE DEVICE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25149714 ↗MalfunctionMar 14, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT 25MM DRILL BIT BENT DURING SCREW PREPARATION. BOTH STEM INSERTERS MUSH ROOMED OUT DURING STEM INSERTION. SURGEON WAS REQUIRED TO KNOCK THE INSERTERS OUT OF THE SHOULDER OF THE STEM AFTER INSERTION. THERE WAS A CONCERN THAT THE GREATER TROCHANTER WAS FRACTURED. SURGICAL DELAY UNKNOWN.
Patient problems: Limb Fracture
MAUDE report 18901736 ↗MalfunctionMay 9, 2022Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE STEM INSERTER TINES ARE WORN DOWN AND BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14338024 ↗MalfunctionMar 26, 2021Device-Device Incompatibility; Device-Device Incompatibility
INSERTER STUCK INSIDE THE INSERTION HOLE OF THE STEM IMPLANT. NO SURGICAL DELAYS OR PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11574036 ↗MalfunctionDec 18, 2020Material Deformation; Material Deformation
IT WAS REPORTED THAT THE STEM IMPACTOR IS DEFORMED AND WILL NOT INSERT INTO THE STEM AND THE TRAY IS CRACKED. NO ADDITIONAL INFORMATION IS AVAILABLE. NO SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11041574 ↗MalfunctionDec 7, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE KINCISE STEM IMPACTOR DOESN'T FIT INTO KINCISE GUN. OFFSET SUMMIT IMPACTOR COLD WELDED TO STEM IMPLANT. WHEN THE DOCTOR DISENGAGED THE IMPACTOR THE STEM CAME OUT WITH IT. PLEASE SEND BOTH REPLACEMENTS SOS TO (B)(6) OFFICE. SURGERY DELAYED FOR 1 MINUTE. NO ADDITIONAL INFORMATION.
Patient problems: Insufficient Information
MAUDE report 10958577 ↗MalfunctionOct 20, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE IMPACTOR WOULD NOT FIT IN SLOTS OF THE SUMMIT STEM FOR FINAL IMPACTION. THE INSERTER TIP WAS TOO WIDE FROM PREVIOUS IMPACTIONS. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10706685 ↗MalfunctionMay 18, 2020Break; Break
IT WAS REPORTED THAT PRIOR TO SURGERY, SCRUB TECH NOTICED THE TIP OF THE SUMMIT STEM INSERTER WAS BROKEN OFF. REMOVED FROM FIELD AND REPLACED. NO ADDITIONAL INFORMATION AVAILABLE. PLEASE SEND REPLACEMENT SOS TOO: (B)(6). NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10067248 ↗MalfunctionMar 17, 2020Break; Break
IT WAS REPORTED THAT BOTH OF THESE PRODUCTS WERE FOUND BROKEN. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9843618 ↗MalfunctionFeb 10, 2020Break; Break
IT WAS REPORTED THAT THE TIP BROKE OFF. SALES REP DON'T KNOW WHEN IT HAPPENED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9688871 ↗MalfunctionFeb 10, 2019Break; Break
IT WAS REPORTED THAT THE TIP OF SUMMIT INSERTED HAS BROKE OFF. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8324689 ↗MalfunctionJan 3, 2019Break; Break
IT WAS REPORTED THAT THE TIP IMPACTOR WAS BROKE WHILE IMPACTING THE STEM. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8211894 ↗MalfunctionDec 3, 2018Break; Break
IT WAS REPORTED THAT BEFORE THE CASE STARTED, THE SURGICAL TECH NOTICED THE INSERTER WAS MISSING THE TIP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8124956 ↗MalfunctionNov 2, 2018Break; Break
IT WAS REPORTED THAT THE IMPACTOR TIP BROKE OFF OF IMPACTOR WHEN PUTTING CORAIL STEM IN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8033105 ↗MalfunctionSep 8, 2017Break; Break
IT WAS REPORTED THAT THE TIP OF THE IMPACTOR BROKE.
Patient problems: No Information
MAUDE report 6851896 ↗
Other DRIVER, PROSTHESIS devices
- ATTUNE 2544-01-005Depuy (Ireland) · DRIVER, PROSTHESIS1,383 reports
- EXPEDIUM VERSE 299704230Medos International Sàrl · DRIVER, PROSTHESIS875 reports
- NA 9200-10-029Depuy (Ireland) · DRIVER, PROSTHESIS745 reports
- MOSS 279712600Depuy Spine, LLC · DRIVER, PROSTHESIS706 reports
- NA 2598-07-440Depuy (Ireland) · DRIVER, PROSTHESIS665 reports
- NA 2598-07-570Depuy (Ireland) · DRIVER, PROSTHESIS505 reports
- VIPER 286745550Depuy Spine, LLC · DRIVER, PROSTHESIS263 reports
- SUMMIT 2570-05-100Depuy (Ireland) · DRIVER, PROSTHESIS225 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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