DELTA XTEND 2307-82-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295116349), received between Aug 18, 2017 and May 13, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT THE CTA HEAD REAMER AND GUIDE WERE SCORED AND BECAME BOUND TOGETHER. SURGEON FINISHED THE BONE PREPARATION BY HAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164946 ↗
• MalfunctionNov 13, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 20679026 ↗
• MalfunctionJul 1, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT INSTRUMENTS WERE HIGHLY WORN AND NEEDED TO BE REPLACED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14885781 ↗
• MalfunctionJul 1, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT INSTRUMENTS WERE HIGHLY WORN AND NEEDED TO BE REPLACED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14885756 ↗
• MalfunctionJun 28, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CTA REAMER WAS WELDED ONTO THE REAMER GUIDE. SURGERY WAS NOT EXTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12080839 ↗
• MalfunctionApr 8, 2021Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  SURGEON HAD CONVERTED TO EXTEND CTA DUE TO POOR GLENOID BONE QUALITY. WHEN HE ATTEMPTED TO PUT DELTA EXTEND CTA HEAD REAMER INTO THE REAMER GUIDE IT WOULD NOT FIT IN ALL THE WAY. SURGEON ATTEMPTED TO BEGIN REAMING AND IT STUCK AND ROTATED THE WHOLE CONSTRUCT, STEM, HEAD REAMER GUIDE AN REAMER. SURGICAL DELAY 10 MINUTES. SURGEON COMPLETED BONE REMOVAL WITH RONGEUR, PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11633355 ↗
• MalfunctionSep 14, 2020Mechanical Jam; Mechanical Jam

  DELTA XTEND: DURING THE CASE, CTA REAMING GUIDE JAMMED WITH THE CTA REAMER. CAUSING THE REAMER TO NOT SPIN IN THE REAMING GUIDE. REAMING GUIDE REMOVED WITH REAMER AND THE CASE CONTINUED AS PER NORMAL. NO TIME ADDED TO THE CASE AS THE INSTRUMENT WAS DONE WITH AT THAT STAGE. WAS VERY DIFFICULT AND TOOK A LOT OF EFFORT TO REMOVE THE REAMER FROM THE REAMING GUIDE - DONE WITH A HAMMER. NO ADVERSE OUTCOMES EXPECTED. NO PATIENT DEMOGRAPHIC IS AVAILABLE. INSTRUMENT SEPARATED AND STERIBAGGED INDIVIDUALLY READY FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10532212 ↗
• MalfunctionJul 23, 2020Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  THE CTA REAMER GOT STUCKED TO THE CTA REAMERGUIDE AFTER REAMING.

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

  MAUDE report 10315584 ↗
• InjuryJan 16, 2019Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  DURING PREPARATION OF THE PROXIMAL HUMERUS FOR THE CTA HEAD THE REAMER GUIDE WAS MOUNTED ON TO THE HUMERAL STEM. WHILE REAMING WITH THE CTA-HEAD-REAMER, THE REAMER SUDDENLY BLOCKED IN THE REAMER-GUIDE. THIS TURNED PRESSURE ON THE HUMERAL STEM AND GENERATED A FRACTURE OF THE PROXIMAL HUMERUS. THIS FRACTURE HAD TO BE FIXED WITH SUTURES. THE OPERATION COULD BE COMPLETED.

  Patient problems: Bone Fracture(s); Not Applicable

  MAUDE report 8252976 ↗
• MalfunctionAug 18, 2017Bent; Connection Problem; Mechanical Jam; Bent; Connection Problem; Mechanical Jam

  IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO IMPLANT AN XTEND CTA HEAD. WHEN REAMING THE LATERAL PROXIMAL HUMERUS, THE REAMER GOT STUCK ON THE GUIDE AND COULD NOT BE REMOVED.

  Patient problems: No Information

  MAUDE report 6805137 ↗