DELTA XTEND 2307-74-010Recalls & reported problems
Depuy (Ireland) · DELTA Xtend PROXIMAL REAMING GUIDE DIA 10 MM · 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 10603295116158), received between Apr 26, 2018 and Oct 21, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
- 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.
MalfunctionOct 21, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) THERE WAS BREAKAGE OF A SHOULDER INSTRUMENT IN THEATRE. WHEN INSERTING THE ¿PROXIMAL REAMER GUIDE¿ FULLY ASSEMBLED, THE PROXIMAL REAMER GUIDE INTERNAL ROD END / STRIKE PLATE SHEARED OFF AND COLD WELDED INTO THE PROXIMAL REAMER BODY. THE DEVICES COULD NOT BE SEPARATED. THE SALES REPRESENTATIVE ACQUIRED A BACKUP SET TO CONTINUE THE OPERATION WHICH CAUSED A SURGICAL DELAY OF LESS THAN ONE (1) MINUTE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20493490 ↗MalfunctionJul 6, 2022Break; Break
THE ROD BROKE INTO TWO PIECES WHEN ATTACHED TO THE REAMER GUIDE. THE REAMER GUIDE SIZE 10 IS ATTACHED TO THE INSTRUMENT. A SMALLER REAMER GUIDE WAS USED TO CONTINUE REAMING. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14936545 ↗MalfunctionApr 26, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE TOP PIECE CAME OFF THE ROD FOR THE REAMING GUIDE HOLDER AND THE SURGEON WAS UNABLE TO GET THE PROXIMAL REAMING GUIDE OFF THE REAMING GUIDE HOLDER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7464021 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 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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