DELTA XTEND 2307-38-406Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295115823), received between Jan 22, 2019 and Jun 8, 2026 — classified as 14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2026Break

  IT WAS REPORTED THAT DURING A SHOULDER REPAIR SURGERY, THE GREEN DISK WAS BROKEN AND THROWN AWAY AFTER THE CASE. THE BLUE HANDLE SCREWDRIVER WAS STRIPPED. THE HUMERAL CUPS WERE ALSO BROKEN AND THROWN AWAY AFTER THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25429357 ↗
• MalfunctionJun 8, 2026Break

  IT WAS REPORTED THAT DURING A SHOULDER REPAIR SURGERY, THE GREEN DISK WAS BROKEN AND THROWN AWAY AFTER THE CASE. THE BLUE HANDLE SCREWDRIVER WAS STRIPPED. THE HUMERAL CUPS WERE ALSO BROKEN AND THROWN AWAY AFTER THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428252 ↗
• MalfunctionJun 27, 2025Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT SURGEON WANTS ALL THE TRIALS REPLACED BECAUSE OF CUTS AND GOUGES AND SAID THEY DIDN'T FIT WELL WHEN TRIALING DUE TO AGE OF TRIALS. THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345541 ↗
• MalfunctionJun 27, 2025Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT SURGEON WANTS ALL THE TRIALS REPLACED BECAUSE OF CUTS AND GOUGES AND SAID THEY DIDN'T FIT WELL WHEN TRIALING DUE TO AGE OF TRIALS. THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345384 ↗
• MalfunctionJun 27, 2025Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT SURGEON WANTS ALL THE TRIALS REPLACED BECAUSE OF CUTS AND GOUGES AND SAID THEY DIDN'T FIT WELL WHEN TRIALING DUE TO AGE OF TRIALS. THIS COMPLAINT IS LINKED TO PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345301 ↗
• MalfunctionJun 27, 2025Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT SURGEON WANTS ALL THE TRIALS REPLACED BECAUSE OF CUTS AND GOUGES AND SAID THEY DIDN'T FIT WELL WHEN TRIALING DUE TO AGE OF TRIALS. THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22344840 ↗
• MalfunctionAug 27, 2024Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT INSTRUMENTS ARE SHOWING SIGNIFICANT WEAR FROM EXCESSIVE USE. BEAT UP TRIALS.

  Patient problems: Insufficient Information

  MAUDE report 20075303 ↗
• MalfunctionSep 12, 2023Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE PLASTIC TRIALS HAVE BECOME SO WORN FROM REDUCING AND BEING USED OVER THE YEARS THAT THEY HAVE STARTED DEVELOPING DEEP ABRASIONS AND CUTS INTO THE PLASTIC. PIECES OF THESE CUTS HAVE BEGUN SEPARATING FROM THE TRIAL. DURING SURGERY, ONE SMALL PIECE CAME OFF IN THE PATIENT BUT WAS IMMEDIATELY RETRIEVED. NO ADVERSE AFFECTS WERE EXPERIENCED BY THE PATIENT. ALL PIECES WERE RETRIEVED AND SURGERY WAS DELAYED BY APPROXIMATELY 17 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17728125 ↗
• MalfunctionJul 5, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT CUP TRIAL IS EXTREMELY WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17254507 ↗
• MalfunctionJul 23, 2020Use of Device Problem; Scratched Material; Use of Device Problem; Scratched Material

  IT WAS REPORTED THAT THE 38 POLY TRIALS ARE DAMAGED WITH SCARS AND MISSING PLASTIC IN AREAS SURGEON AND SPD WANTED THEM REPLACED. PROTECTIVE PLATE IS BENT AND WON¿T SIT FLUSH ON THE BONE. THE REAMERS ARE DULLED AND HAVE BURRS . THESE ITEMS WERE PULLED OUT OF THE SETS AND NOT USED IN A CASE.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10314357 ↗
• MalfunctionJul 23, 2020Use of Device Problem; Scratched Material; Use of Device Problem; Scratched Material

  IT WAS REPORTED THAT THE 38 POLY TRIALS ARE DAMAGED WITH SCARS AND MISSING PLASTIC IN AREAS SURGEON AND SPD WANTED THEM REPLACED. PROTECTIVE PLATE IS BENT AND WON¿T SIT FLUSH ON THE BONE. THE REAMERS ARE DULLED AND HAVE BURRS . THESE ITEMS WERE PULLED OUT OF THE SETS AND NOT USED IN A CASE.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10314310 ↗
• MalfunctionJan 22, 2019Break; Break

  IT WAS REPORTED THAT THE HUMERAL CUP TRIALS HAVE SHAVING OF PLASTIC COMING OFF OF THEM. HAD TO OPEN THREE DIFFERENT TRAYS FOR CASE. ALL WENT WELL AND NOTHING LEFT IN PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8269011 ↗
• MalfunctionJan 22, 2019Break; Break

  IT WAS REPORTED THAT THE HUMERAL CUP TRIALS HAVE SHAVING OF PLASTIC COMING OFF OF THEM. HAD TO OPEN THREE DIFFERENT TRAYS FOR CASE. ALL WENT WELL AND NOTHING LEFT IN PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8269001 ↗
• MalfunctionJan 22, 2019Break; Break

  IT WAS REPORTED THAT THE HUMERAL CUP TRIALS HAVE SHAVING OF PLASTIC COMING OFF OF THEM. HAD TO OPEN THREE DIFFERENT TRAYS FOR CASE. ALL WENT WELL AND NOTHING LEFT IN PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8268989 ↗