SUMMIT 2570-02-100Recalls & reported problems
Depuy (Ireland) · SUMMIT TAPERED REAMER SIZE 2/3 · Class 1
All models of SUMMIT (43)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Summit tapered reamer is a surgical instrument used to prepare bone for hip implant surgery. The 28 reports mostly describe reamers that would not cut, had become dull or worn out from repeated use, did not fit the matching handle, twisted or bent, or broke, all noticed during hip surgery and generally causing no surgical delays or harm to the patient. There are 28 malfunction reports, with no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10603295143000), received between Dec 4, 2018 and Oct 29, 2024 — classified as 28 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (12 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.
Reports received per month
Most reported problems
Device problems
- Failure to Cut12
- Dull, Blunt9
- Naturally Worn6
- Device-Device Incompatibility5
- Material Twisted/Bent3
- Break2
- Illegible Information2
- Difficult to Insert1
Patient problems
- No Consequences Or Impact To Patient13
- No Clinical Signs, Symptoms or Conditions10
- Insufficient Information4
- Not Applicable1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 29, 2024Failure to Cut; Failure to Cut
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAYS OR NEGATIVE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20556572 ↗MalfunctionOct 29, 2024Failure to Cut; Failure to Cut
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAYS OR NEGATIVE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20556536 ↗MalfunctionOct 11, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP SURGERY ON (B)(6) 2024. THE HOSPITAL STAFF DROPPED THE BIPOLAR RETAINING CLIP ON THE FLOOR AND THREW IT IN THE TRASH. ALSO, THE SUMMIT REAMERS HAVE BECOME DULL. THIS DID NOT DELAY SURGERY. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 20429750 ↗MalfunctionOct 11, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP SURGERY ON (B)(6) 2024. THE HOSPITAL STAFF DROPPED THE BIPOLAR RETAINING CLIP ON THE FLOOR AND THREW IT IN THE TRASH. ALSO, THE SUMMIT REAMERS HAVE BECOME DULL. THIS DID NOT DELAY SURGERY. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 20429569 ↗MalfunctionOct 11, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP SURGERY ON (B)(6) 2024. THE HOSPITAL STAFF DROPPED THE BIPOLAR RETAINING CLIP ON THE FLOOR AND THREW IT IN THE TRASH. ALSO, THE SUMMIT REAMERS HAVE BECOME DULL. THIS DID NOT DELAY SURGERY. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 20429543 ↗MalfunctionMar 18, 2024Break; Break
IT WAS REPORTED THAT THE REAMER HANDLE IS BROKEN. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? UNKNOWN. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED? UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18921435 ↗MalfunctionOct 24, 2023Failure to Cut; Failure to Cut
IT WAS REPORTED THAT DURING HIP HEMIARTHROPLASTY, SURGEON NOTED THAT THE SUMMIT SZ2/3 TAPERED REAMER WAS DULL. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 17998139 ↗MalfunctionOct 20, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6), 2023, THE PATIENT UNDERWENT A BHA. DURING SURGERY, THE T-HANDLE IN QUESTION AND A REAMER DID NOT MATCH, SO THE T-HANDLE IN QUESTION COULD NOT BE USED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17974304 ↗MalfunctionMay 4, 2022Naturally Worn; Naturally Worn
INSTRUMENTS ARE WORN. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14274211 ↗MalfunctionMay 4, 2022Naturally Worn; Naturally Worn
INSTRUMENTS ARE WORN. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14274193 ↗MalfunctionMay 4, 2022Naturally Worn; Naturally Worn
INSTRUMENTS ARE WORN. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14274121 ↗MalfunctionMay 4, 2022Naturally Worn; Naturally Worn
INSTRUMENTS ARE WORN. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14274108 ↗MalfunctionMay 4, 2022Naturally Worn; Naturally Worn
INSTRUMENTS ARE WORN. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14274047 ↗MalfunctionAug 12, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT WHEN THE SURGEON USED THE REAMER WITH A HANDPIECE AND CHUCK, THE REAMER STUCK INTO THE BONE AND ONLY THE HANDPIECE ROTATED. IN THAT TIME, THE CONNECTION PART BETWEEN THE REAMER AND CHUCK BROKE AND THE SURGEON COULDN¿T DISCONNECT THEM. THE SURGEON REMOVED THE REMAINED REAMER IN THE CAVITY WITH PLIERS AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS A SURGICAL DELAY OF FIVE MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12312020 ↗MalfunctionMar 20, 2020Dull, Blunt; Failure to Cut; Material Twisted/Bent; Illegible Information; Dull, Blunt; Failure to Cut; 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 9859648 ↗MalfunctionMar 20, 2020Dull, Blunt; Failure to Cut; Material Twisted/Bent; Illegible Information; Dull, Blunt; Failure to Cut; 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 9859640 ↗MalfunctionFeb 5, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE SUMMIT STRAIGHT REAMER SIZES 0-1,2-3,4-5,6-7,8-9, AND LATERALIZER ARE STRIPPED AT THE TOP AND WILL NOT WORK PROPERLY IN THE HUDSON ADAPTOR. NO PIECES ARE BROKEN AND ALL PARTS WERE RETRIEVED AND SENT TO THE OFFICE. THE SCRUB TECHNIQUE MADE ME AWARE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9672574 ↗MalfunctionJan 23, 2020Device-Device Incompatibility; Device-Device Incompatibility
SUMMIT REAMERS WERE NOT PROPERLY ENGAGING INTO THE ADAPTER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9619776 ↗MalfunctionOct 30, 2019Loss of or Failure to Bond; Dull, Blunt; Failure to Cut; Loss of or Failure to Bond; Dull, Blunt; Failure to Cut
IT WAS REPORTED THAT THE SUMMIT SZ0/1, 2/3, 4/5, 6/7, 8/9 TAPERED REAMER ARE ALL DULL. NEEDS REPLACEMENT X'S 4.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9257719 ↗MalfunctionOct 30, 2019Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut
IT WAS REPORTED THAT THE SUMMIT SZ0/1, 2/3, 4/5, 6/7, 8/9 TAPERED REAMER ARE ALL DULL. NEEDS REPLACEMENT X'S 4.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9257718 ↗MalfunctionOct 30, 2019Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut
IT WAS REPORTED THAT THE SUMMIT SZ0/1, 2/3, 4/5, 6/7, 8/9 TAPERED REAMER ARE ALL DULL. NEEDS REPLACEMENT X'S 4.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9257717 ↗MalfunctionOct 30, 2019Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut
IT WAS REPORTED THAT THE SUMMIT SZ0/1, 2/3, 4/5, 6/7, 8/9 TAPERED REAMER ARE ALL DULL. NEEDS REPLACEMENT X'S 4.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9257715 ↗MalfunctionJul 15, 2019Dull, Blunt; Dull, Blunt
THE SUMMIT TAPERED REAMERS NEED REPLACEMENTS. THE SURGEON FEELS THAT THEY AREN¿T SHARP ENOUGH.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8790217 ↗MalfunctionJul 15, 2019Dull, Blunt; Dull, Blunt
THE SUMMIT TAPERED REAMERS NEED REPLACEMENTS. THE SURGEON FEELS THAT THEY AREN¿T SHARP ENOUGH.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8790215 ↗MalfunctionJul 15, 2019Dull, Blunt; Dull, Blunt
THE SUMMIT TAPERED REAMERS NEED REPLACEMENTS. THE SURGEON FEELS THAT THEY AREN¿T SHARP ENOUGH.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8790204 ↗
Other REAMER devices
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- QUICKSET 2440-00-549Depuy (Ireland) · REAMER1,113 reports
- QUICKSET 2440-00-553Depuy (Ireland) · REAMER1,105 reports
- QUICKSET 2440-00-547Depuy (Ireland) · REAMER1,073 reports
- QUICKSET 2440-00-555Depuy (Ireland) · REAMER1,065 reports
- QUICKSET 2440-00-557Depuy (Ireland) · REAMER1,031 reports
- QUICKSET 2440-00-545Depuy (Ireland) · REAMER947 reports
- QUICKSET 2440-00-552Depuy (Ireland) · REAMER888 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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