DELTA XTEND 2307-71-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295116073), received between Nov 3, 2017 and Nov 5, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (10 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A TOTAL SHOULDER REPLACEMENT PROCEDURE, IT WAS DISCOVERED THAT A PIECE OF THE ORIENTATION PIN WAS BENT. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WERE NO FRAGMENTS GENERATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476436 ↗
• MalfunctionOct 20, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE DELTA XTEND ORIENTATION PIN WAS BENT AND WILL NOT FIT THROUGH THE CUTTING GUIDE HANDLE HOLE OR TRIAL/IMPLANT/INTRODUCER. WITHOUT THE ORIENTATION PIN, THIS MAKES IT IMPOSSIBLE FOR THE SURGEON TO KNOW WHETHER HE HAS PLACED THE INSTRUMENTS IN THE CORRECT ORIENTATION. THIS WILL BE DETRIMENTAL TO THE FINAL POSITION AND IMPLANTATION AND MAY CAUSE IMPLANT FAILURE. THIS DID NOT DELAY SURGERY OR HARM THE PATIENT AS HE WAS ABLE TO USE THE 2.5MM GUIDE PIN INSTEAD, BEING CAUTIOUS OF THE POINTED TIP HOWEVER, SO AS NOT TO DAMAGE SURROUNDING SOFT TISSUE OR NERVES. DUE TO ONGOING USE OVER TIME, THE END OF THE DELTA XTEND LOCKING SCREWDRIVER INTERNAL ROD HAS BECOME ROUNDED AND MIS-SHAPED, MAKING IT VERY DIFFICULT ENGAGING AND INSERTING THE INTERNAL LOCKING SCREW. THIS DELAYED SURGERY BY ONLY 10 MINUTES UNTIL A SECOND INSTRUMENT TRAY WAS OPENED AND USED IN PLACE OF THE WORN INSTRUMENT. THERE WAS NO HARM TO THE PATIENT. DUE TO ONGOING USE OVER TIME, THE END OF THE DELTA XTEND 3.5MM CANNULATED HEX SCREWDRIVER HAS BECOME ROUNDED AND MIS-SHAPED, MAKING IT VERY DIFFICULT ENGAGING AND INSERTING THE NON-LOCKING LOCKING SCREW. THIS DID NOT DELAY SURGERY AS A SECOND INSTRUMENT TRAY W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335649 ↗
• MalfunctionMay 12, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ORIENTATION PIN (VERSION ROD) ON DELTA EXTEND WAS FOUND TO BE BENT ON SET INSPECTION PRIOR TO CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22004017 ↗
• MalfunctionMar 27, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025. WHEN OPENING THE SETS PRIOR TO SURGERY, IT WAS DETERMINED THAT THE DEPTH GAUGE AND VERSION ROD WERE BOTH BENT.

  Patient problems: Insufficient Information

  MAUDE report 21708055 ↗
• MalfunctionNov 18, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THE ORIENTATION GUIDE PIN BENT. IT WAS NOTED THE HOSPITAL DISCARDED IT. THERE WAS PATIENT CONSEQUENCES NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20708934 ↗
• MalfunctionFeb 29, 2024Material Deformation; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS STATED THAT THE OPERATION WAS ON THE (B)(6) AND THAT THERE WAS NO DELAY TO THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18812818 ↗
• MalfunctionFeb 9, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT PIN IS BENT. NO PIECES WERE LEFT INSIDE PATIENT. SURGICAL DELAY UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18675506 ↗
• MalfunctionFeb 6, 2024Break; Break

  IT WAS REPORTED THAT THE PIN BROKE NO PIECES WERE LEFT IN PATIENT. IT WAS UNKNOWN ABOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18650953 ↗
• MalfunctionJan 17, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ORIENTATION PIN BENT. PROXIMAL REAMING GUIDE HANDLE WAS LOOSE AND WOULD NOT HOLD.

  Patient problems: Insufficient Information

  MAUDE report 18524958 ↗
• MalfunctionJun 26, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ORIENTATION PIN IS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17199736 ↗
• MalfunctionDec 21, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ORIENTATION PIN WAS BENT DURING THE CASE AND WAS NOT ABLE TO BE USED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16023647 ↗
• MalfunctionMay 18, 2022Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE INSTRUMENTS ARE BROKEN AND DAMAGED FROM WASH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14428809 ↗
• MalfunctionJan 28, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE BLUE ROD GOT BENT MAKING IT DIFFICULT TO ALIGN THE INSTRUMENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9637701 ↗
• MalfunctionOct 25, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE ORIENTATION PIN WAS BENT DURING INSERTION OF STEM TRIAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8006379 ↗
• MalfunctionAug 14, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE VERSION ROD WAS BENT AND DISCARDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7781039 ↗
• MalfunctionNov 3, 2017Break; Break

  IT WAS REPORTED THAT BLUE PIN GUIDE CRACKED AND BROKE IN TWO PIECES.

  Patient problems: No Information

  MAUDE report 6998911 ↗