SUMMIT 2570-03-350Recalls & reported problems
Depuy (Ireland) · SUMMIT NECK SEGMENT SIZE 6/7 HI · Class 1
All models of SUMMIT (43)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295143123), received between Jan 5, 2018 and Nov 19, 2025 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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
- Device-Device Incompatibility2
- Material Twisted/Bent2
- Break1
- Component Missing1
- Illegible Information1
- Material Deformation1
- Material Discolored1
Patient problems
- No Consequences Or Impact To Patient4
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 19, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT PROCEDURE IT WAS OBSERVED THAT THE TRIAL WOULD NOT SIT ATOP THE BROACH TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23597759 ↗MalfunctionSep 23, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE RING AROUND THE SUMMIT 6/7 HIGH NECK TRIAL AND THE 4/5 HIGH OFFSET NECK TRIAL HAD BENT SO THAT THE HEAD WAS NOT STAYING ON.
Patient problems: Insufficient Information
MAUDE report 20278437 ↗MalfunctionJul 20, 2023Break; Break
IT WAS REPORTED THAT THE HEAD IMPACTOR WAS BROKEN. IT WAS CHEWED UP AND NO LONGER SMOOTH. NO SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17365272 ↗MalfunctionMar 29, 2021Illegible Information; Illegible Information
IT WAS REPORTED THAT THE NECK SEGMENT LABEL RUBBED OFF. THE "6/7 HI" WAS NOT VISIBLE. NO ADDITIONAL INFORMATION. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11585751 ↗MalfunctionMar 10, 2020Material Twisted/Bent; Material Twisted/Bent
MalfunctionMar 10, 2020Material Twisted/Bent; Material Twisted/Bent
MalfunctionJul 5, 2018Material Discolored; Material Discolored
PRODUCTS PRESENTED OXIDATION. IN THE EMAIL RECEIVED, CAME A LIST OF PRODUCTS SEPARATED BY BOX. THIS COMPLAINT REFERS TO THE PRODUCTS OF (B)(6) HOSPITAL IN BOX 1. (B)(6). PRODUCT: 257003050, LOT: MT40595. PRODUCT: 257003250, LOT: MT47299. PRODUCT: 257003350, LOT: MT45800. PRODUCT: 257003200, LOT: MT47074. PRODUCT: 257003300, LOT: MT47294.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7663414 ↗MalfunctionJan 5, 2018Component Missing; Component Missing
IT WAS REPORTED THAT THE SNAP RING WAS MISSING FROM NECK TRIAL. SURGICAL DELAY FOR 5 MINUTES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7167388 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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.
How reports and recalls are matched · Editorial policy · Report an error on this page