DELTA XTEND 2307-84-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295518785), received between Mar 1, 2023 and Jun 2, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (7 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

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Break

  IT WAS REPORTED THAT DURING SHOULDER REPAIR SURGERY THE IMPLANT INSERTER BROKE IN HALF. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363275 ↗
• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT THE HANDLE BROKEN IN HALF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24220889 ↗
• MalfunctionOct 31, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PRIMARY TOTAL SHOULDER ARTHROPLASTY, THE TRIAL HANDLE¿S LATCH DID NOT LOCK WITH THE TRIAL. IT WAS ALSO REPORTED THAT THE SIZE 2 RIGHT EPIPHYSIS DID NOT THREAD INTO STEM TRIALS WITH THE YELLOW SCREWDRIVER. THERE WERE NO BROKEN PIECES, DELAYS OR COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439686 ↗
• MalfunctionMay 12, 2025Break; Break

  IT WAS REPORTED THAT THE STERILE PROCESSING DEPARTMENT INFORMED THAT THE INSTRUMENT BROKE WHILE BEING WASHED. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22003168 ↗
• MalfunctionSep 9, 2024Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT SHEARED OFF TOO.

  Patient problems: Insufficient Information

  MAUDE report 20168492 ↗
• MalfunctionJul 8, 2024Break; Break

  IT WAS REPORTED THAT THE REP NOTICED THE HANDLE HAD A CRACK IN HALF AFTER WASHING AND IT WAS REMOVED FROM USE. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19688891 ↗
• MalfunctionFeb 26, 2024Break; Break

  IT WAS REPORTED THAT AFTER WASHING, THE HANDLE BROKE IN HALF. THERE WAS NO DELAY NOR HARM TO THE PATIENT. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777059 ↗
• MalfunctionMar 7, 2023Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT THE SURGEON UTILISING DELTA XTEND 145 EPIPHYSIS INSTRUMENTS. AFTER PLACING THE TRAIL STEM ON THE 145 RSA IMPLANT INSERTER AND IMPACTING THE TRIAL INTO THE HUMERUS, THE SURGEON STATED HE HAD DIFFICULTY IN DISENGAGING THE HANDLE FROM THE TRIAL. SURGEON STATES HE FEELS THE IMPACTOR HANDLE IS 'TOO STIFF AND NOT EASY TO DISENGAGE FROM THE TRIAL.' HANDLE WAS SUCCESSFULLY DISENGAGED AFTER SEVERAL ATTEMPTS AND SURGERY PROCEEDED AS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16494434 ↗
• MalfunctionMar 1, 2023Break; Break

  IT WAS REPORTED THAT THE HANDLE BROKE WHILE EXTRACTING STEM FOR INFECTION. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16461324 ↗