DELTA XTEND 2307-78-004Recalls & reported problems
Depuy (Ireland) · DELTA Xtend PROXIMAL REAMER FOR MODULAR IMPLANT SZ 2 · Class 1
All models of DELTA XTEND (194)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295116257), received between Jul 31, 2019 and Nov 17, 2021 — classified as 3 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.
Most reported problems
Device problems
- Device-Device Incompatibility2
- Dull, Blunt1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 17, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE EPI 2 RED PROXIMAL HUMERAL REAMER CHUCK CONNECTION WAS DAMAGED AND WOULD NOT CONNECT TO THE HUDSON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12827844 ↗MalfunctionSep 20, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE REAMING ADAPTOR WAS BROKEN WHEN IT CAME TO THE CUSTOMER. IT WAS NOTICED DURING THE SURGERY THAT THIS ITEM WELDS TOGETHER (GETS STUCK) WITH THIS REAMER. THIS MIGHT CAUSE A HUMERUS FRACTURE; LUCKILY THIS WAS AVOIDED THIS TIME DUE TO A VERY EXPERIENCED SURGEON. THE LOAN SET WILL BE RETURNED LATER THIS WEEK AND IT´S VERY IMPORTANT THAT THIS INSTRUMENT WILL BE REPLACED. THE REAMER MIGHT BE DAMAGED AS WELL DUE TO THE DEFECT INSTRUMENT SO PLEASE CHECK THAT AS WELL. THERE WAS A TEN-MINUTE SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12497276 ↗MalfunctionJul 31, 2019Dull, Blunt; Dull, Blunt
IT WAS REPORTED THAT THE SURGEON COMMENTED THAT THE EPIPHYSIS REAMER WAS VERY DULL. SURGEON HAD A HARD TIME REAMING. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8846122 ↗
Other REAMER devices
- QUICKSET 2440-00-551Depuy (Ireland) · REAMER1,150 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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