DELTA XTEND 2307-67-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10603295116004), received between Sep 7, 2017 and Mar 5, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (13 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 25 most recent of 26 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 24519696 ↗
• MalfunctionFeb 2, 2026Break

  IT WAS REPORTED THAT THE TIP WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24236968 ↗
• MalfunctionNov 25, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE INSTRUMENT IS DAMAGED AND HOLDING A STAIN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23643293 ↗
• MalfunctionJan 15, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING ROUTINE INSTRUMENT ASSEMBLY FOR A SHOULDER REPAIR, IT WAS DISCOVERED THAT THE IMPACTOR TIP THREADS WERE WORN OUT, PREVENTING IT FROM THREADING ONTO THE IMPACTOR HANDLE CORRECTLY. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21160850 ↗
• MalfunctionSep 20, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE CUP IMPACTOR TIP WAS DAMAGED DUE TO USE OF A SHARP INSTRUMENT AND STERILE PROCESSING WILL NOT REPROCESS THE INSTRUMENT. THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20266156 ↗
• MalfunctionAug 28, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE IMPACTOR TIP WAS WORN. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20085543 ↗
• MalfunctionDec 27, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE CUP IMPACTOR TIP IS STRIPPED WON'T LOCK ON HANDLE .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18399505 ↗
• MalfunctionJul 5, 2023Naturally Worn; Naturally Worn

  THE INNER THREADS ARE STRIPPED ON THE RETURNED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17255659 ↗
• MalfunctionJun 1, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE ITEM WAS NOT FIT FOR PATIENT USE DUE TO WEAR AND TEAR. THE WEAR AND TEAR IS GENERAL WEAR AND TEAR WE SEE ON THIS SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17041605 ↗
• MalfunctionMay 31, 2023Naturally Worn; Naturally Worn

  DEVICE WAS REPORTED FOR GENERAL WEAR AND TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17032428 ↗
• MalfunctionMar 4, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE INTERNAL THREAD OF POLY IMPACTOR WORN. NOT GOOD PURCHASE ONTO THE HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13665998 ↗
• MalfunctionFeb 22, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IMPACTOR TIP WAS STRIPPED AND WOULD NOT ATTACH TO THE IMPACTOR CORRECTLY. NO PIECES BROKEN OFF. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13578373 ↗
• MalfunctionFeb 9, 2022Naturally Worn; Naturally Worn

  THE CUP IMPACTOR TIP THREADS ARE STRIPPED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13496016 ↗
• MalfunctionDec 6, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE BLACK TIP ON DEPTH GAUGE IS CROSS THREADED. CUP IMPACTOR TIP IS CROSS THREADED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12935499 ↗
• MalfunctionJul 30, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE THREADS ON THE INSTRUMENT ARE CROSS THREADED. IT WILL NOT SCREW ON TO THE HANDLE. NOT USED IN A CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12252765 ↗
• MalfunctionJul 23, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT THE HUMERAL CUP IMPACTOR WOULD NOT THREAD INTO THE METAL HANDLE. IT IS BELIEVED THAT THE PLASTIC IS STRIPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12217766 ↗
• MalfunctionApr 20, 2021Use of Device Problem; Material Twisted/Bent; Use of Device Problem; Material Twisted/Bent

  IT WAS REPORTED THAT THE THREADS WERE DAMAGED TO HOLD ON HANDLE. IT WAS ALSO REPORTED THAT THE SPD MISPLACED THE INSTRUMENT TO FOR RETURN. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11697590 ↗
• MalfunctionJan 6, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE HUMERAL CUP IMPACTOR TIP WILL NOT STAY THREADED TO THE IMPACTOR HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11127127 ↗
• MalfunctionJul 29, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE THREADS ARE STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10338680 ↗
• MalfunctionJan 23, 2020Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE THREADS ON HUMERAL CUP IMPACTOR ARE DAMAGED AND IT WON¿T THREAD ONTO THE IMPACTOR HANDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9623209 ↗
• MalfunctionJul 24, 2019Crack; Naturally Worn; Crack; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED INDICATING THAT THE TIP OF THE IMPACTOR WAS WORN & BEGINNING TO CRACK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8821660 ↗
• MalfunctionMay 30, 2019Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT THE PIECE IS WORN DOWN CHIPPING NEEDS REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8656011 ↗
• MalfunctionFeb 19, 2019Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE THREADS STRIPPED WON¿T STAY ON HANDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8351169 ↗
• MalfunctionDec 1, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE POLY IMPACTOR THREADS WERE STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7075282 ↗
• MalfunctionOct 23, 2017Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE HEAD IMPACTOR TIP STRIPPED.

  Patient problems: No Information

  MAUDE report 6968615 ↗