DELTA XTEND 2307-88-242Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295116486), received between Feb 24, 2020 and Apr 16, 2024 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (11 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2024Break; Break

  IT WAS REPORTED THAT THE REAMER WAS BROKEN. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19116395 ↗
• MalfunctionNov 3, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE INSTRUMENTS WERE TOO DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18064519 ↗
• MalfunctionNov 3, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE INSTRUMENTS WERE TOO DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18064514 ↗
• MalfunctionNov 3, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE INSTRUMENTS WERE TOO DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18064511 ↗
• MalfunctionMay 5, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT BONE DEBRIS WAS ADHERING TO THE JAGGED PART OF THE REAMER IN QUESTION BEFORE SURGERY. IT IS UNKNOWN IF THE BONE DEBRIS IS A BONE MODEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16878387 ↗
• MalfunctionApr 4, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DEVICE WAS DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16674063 ↗
• MalfunctionApr 4, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE DEVICE WAS DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16673964 ↗
• MalfunctionMar 1, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE GLENOID MANUAL REAMER 42MM HAD 'OLD BONE DEBRIS FROM A PREVIOUS PATIENT STILL IN THE REAMER HEAD'.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16460582 ↗
• MalfunctionOct 5, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE SURGEON HAD TROUBLE ENGAGING THE GLENOSPHERE DUE TO SUPERIOR BONE LEFT BEHIND AFTER REAMING WITH A DULL WILSON REAMER. THIS IS THE THIRD INSTANCE IN WHICH THE SURGEON HAS ENCOUNTERED THIS ISSUE. THERE WAS A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15542547 ↗
• MalfunctionJul 15, 2022Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE DELTA REVERSE MANUAL REAMERS HAD CORROSION ON THE INSIDE UNABLE TO STERILIZE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15029160 ↗
• MalfunctionJul 5, 2022Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE INSTRUMENT WAS REPORTED TO BE BROKEN/WORN OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14914621 ↗
• MalfunctionFeb 8, 2022Failure to Cut; Failure to Cut

  REAMER IS DULL. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13482398 ↗
• MalfunctionFeb 8, 2022Failure to Cut; Failure to Cut

  REAMER IS DULL. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13482395 ↗
• MalfunctionOct 27, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE REAMER COULD NOT REAM THE BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12703476 ↗
• MalfunctionJul 28, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TREATING REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2021. THE SURGEON USED THE REAMERS FOR SCRAPING THE BONE. SINCE THE REAMERS WERE NOT SHARP ENOUGH, THE SURGEON HAD DIFFICULTY IN SCRAPING THE BONE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12239431 ↗
• MalfunctionApr 26, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE INSTRUMENT IS NOT IN SHAPE NEEDS TO BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729038 ↗
• MalfunctionSep 24, 2020Contamination /Decontamination Problem; Scratched Material; Contamination /Decontamination Problem; Scratched Material

  DELTA XTEND SHOULDER REPLACEMENT PROCEDURE, DURING PREPARATION OF THE GLENOID, JUST PRIOR TO USING THE PERIPHERAL REAMER, DEBRIS WAS NOTED ON THE REAMER FACE. INSTRUMENT WAS NOT USED, SCRUB NURSE HANDED OFF THE INSTRUMENT PRIOR TO TOUCHING THE AREA WITH THE UNKNOWN DEBRIS, AND ALSO CHANGED HER GLOVES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10583161 ↗
• MalfunctionFeb 24, 2020Dull, Blunt; Failure to Cut; Material Twisted/Bent; Dull, Blunt; Failure to Cut; Material Twisted/Bent

  IT WAS REPORTED THAT THE INSTRUMENT WAS DULL FROM COMMON WEAR AND TEAR. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9745637 ↗