DELTA XTEND 2307-68-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295116011), received between Jul 21, 2017 and Mar 5, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionMar 5, 2026Material Deformation

  IT WAS REPORTED THAT THE THREADS ON THE DEVICES WERE DESCRIBED AS CHEWED UP AND REQUIRING REPLACEMENT. THE EVENT DID NOT RESULT IN ANY PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519695 ↗
• MalfunctionAug 10, 2023Break; Break

  IT WAS REPORTED THAT THE DEVICE BROKE. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17498913 ↗
• MalfunctionFeb 21, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT WHILE THE SCRUB TECH WAS TRYING TO THREAD THE HANDLE INTO THE POLY IMPACTOR; SHE NOTICED THAT THE THREADS INSIDE WERE STRIPPED. NO ADVERSE EVENTS OCCURRED AND THERE WAS NO DELAY IN SURGICAL TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16409619 ↗
• MalfunctionJun 22, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT SPECIAL IMPACTOR TIP WAS FOUND TO NOT THREAD ONTO HANDLE .GROVES INSIDES APPEAR TO BE WORN DOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14778891 ↗
• MalfunctionJul 22, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE THREADS ARE STRIPPED. NO SURGICAL DELAY.

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

  MAUDE report 10308880 ↗
• MalfunctionNov 25, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE CLEANING OF THE INSTRUMENTS, A CRACK WAS DISCOVERED IN THE ECCENTRIC GLENOSPHERE ORIENTATION GUIDE AND THE SPACER IMPACTOR TIP WAS STRIPPED AND CANNOT BE FULLY TIGHTENED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9368987 ↗
• MalfunctionFeb 19, 2019Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE THREADS STRIPPED WON¿T TIGHTEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8351218 ↗
• MalfunctionNov 9, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE INSIDE THREADING OF SPACER TIP WAS STRIPPED AND WILL NOT STAY ON HEAD IMPACTOR HANDLE.

  Patient problems: No Information

  MAUDE report 7013721 ↗
• MalfunctionJul 21, 2017Break; Break

  IT WAS REPORTED THAT THE POLY TIPS OF THE IMPACTOR WAS WORN OUT. ON (B)(6) 2017 - EVALUATION OF THE RETURNED TIPS FOUND TWO LOTS WITH PIECES OF MATERIAL MISSING. LOTS 5236860 & 5091011.

  Patient problems: No Information

  MAUDE report 6732346 ↗
• MalfunctionJul 21, 2017Break; Break

  IT WAS REPORTED THAT THE POLY TIPS OF THE IMPACTOR WAS WORN OUT. (B)(6) 2017 - EVALUATION OF THE RETURNED TIPS FOUND TWO LOTS WITH PIECES OF MATERIAL MISSING. LOTS 5236860 & 5091011 K. POTTER.

  Patient problems: No Information

  MAUDE report 6732339 ↗