DELTA XTEND 2307-95-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 315 adverse event reports that list this exact device (DI 10603295116592), received between Jul 25, 2017 and Sep 18, 2026 — classified as 2 injuries, 313 malfunctions.

The most frequently reported specific device problem is “Break” (229 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 315 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Break

  It was reported that during an unspecified surgical procedure it was observed that the guide tip of the GLENOSPHERE ORIENTATION GUIDE broke off. It was reported that no particles were left in the patient. It was reported that there was no significant delay in the procedure due to the event. It was reported that there was no patient or user injury. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828747 ↗
• MalfunctionMay 22, 2026Material Deformation

  IT WAS REPORTED THAT GLENOSPHERE ORIENTAION HANDLE BENT, BUT DID NOT BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257148 ↗
• MalfunctionApr 15, 2026No Apparent Adverse Event

  THERE WAS UNKNOWN ALLEGATION AGAINST THE TIP OF THE ROTATION TOOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24889197 ↗
• MalfunctionMar 10, 2026Break

  IT WAS REPORTED THAT GLENOSPHERE ORIENTATION HANDLE BROKE INTO TWO PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558580 ↗
• MalfunctionMar 3, 2026Break

  IT WAS REPORTED THAT ORIENTATION GUIDE METAL TIP BROKE OFF IN GLENOSPHERE INTRAOPERATIVELY. IT WAS RETRIEVED AND PATIENT WAS X-RAYED FOR DEBRIS AFTER CASE TO ENSURE PATIENT SAFETY. NO DEBRIS FOUND. DAMAGED INSTRUMENT WAS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497451 ↗
• MalfunctionFeb 3, 2026Break

  IT WAS REPORTED THAT INTRAOPERATIVELY IT WAS FOUND THAT THERE WAS A TEAR IN THE PE AT THE TIP. IN ORDER TO PREVENT MATERIAL FROM BEING TORN OFF IN THE PATIENT, THE SURGEON DECIDED TO USE ANOTHER INSTRUMENT. THERE WAS NO PATIENT HAZARD AT ANY TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248836 ↗
• MalfunctionNov 21, 2025Break; Break

  IT WAS REPORTED THAT THE ORIENTATION HANDLE WAS BROKEN. THE EVENT DID NOT HAPPENED DURING A SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617834 ↗
• MalfunctionNov 17, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT TIP BROKE OFF IN WASHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23570964 ↗
• MalfunctionNov 17, 2025Break; Break

  IT WAS REPORTED THAT ORIENTATION HANDLE BROKE DURING CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23570271 ↗
• MalfunctionNov 14, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23560084 ↗
• MalfunctionNov 13, 2025Break; Break

  THE PLASTIC RING AT THE TIP OF THE GLENOSPHERE ORIENTATION GUIDE BROKE. THERE WAS NO SURGERY DELAY DUE TO THE REPORTED EVENT. IT IS UNKNOWN WHETHER THE PROCEDURE WAS COMPLETED SUCCESSFULLY. FRAGMENTS WERE GENERATED BUT REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. IT IS UNKNOWN WHETHER THERE WERE ANY OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION). IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544380 ↗
• MalfunctionNov 13, 2025Break; Break

  IT WAS REPORTED THAT THE WHITE SLEEVE WAS FOUND TO HAVE BROKEN WHILE STERILIZING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544009 ↗
• MalfunctionSep 19, 2025Break; Break

  IT WAS REPORTED THAT GLENOSPHERE ECCENTRICITY HANDLE BROKEN ON IMPACTION. ALL PIECES WERE RETRIEVED. NO CASE DELAY. NO OTHER INFORMATION KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096918 ↗
• MalfunctionAug 29, 2025Break; Break

  IT WAS REPORTED THAT THE TIP OF THE GLENOSPHERE ORIENTATION GUIDE BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22924148 ↗
• MalfunctionAug 28, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT IS BROKEN. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22913794 ↗
• MalfunctionAug 8, 2025Break; Break

  IT WAS REPORTED THAT THE GUIDE TIP BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22754785 ↗
• MalfunctionJul 14, 2025Break; Break

  IT WAS REPORTED THAT THE PLASTIC TIP BROKE OFF FROM HANDLE DURING IMPACTION OF GLENOSPHERE. PIECE WAS RETRIEVED. THERE WAS NO DELAY OR ADVERSE EFFECT FROM THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22493764 ↗
• MalfunctionJul 9, 2025Break; Break

  IT WAS REPORTED THAT THE METAL TIP OF GLENOSPHERE ORIENTATION GUIDE BROKE OFF INTO TWO PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22464220 ↗
• MalfunctionJul 2, 2025Break; Break

  IT WAS REPORTED A GLENOSPHERE ORIENTATION GUIDE WAS BROKEN. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22386513 ↗
• MalfunctionJun 26, 2025Break; Break

  IT WAS REPORTED THAT PLASTIC TIP OR ORIENTATION DEVICE BROKE DURING SURGERY. PIECE WAS RETRIEVED AND CASE WASN'T DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341243 ↗
• MalfunctionMay 15, 2025Crack; Crack

  IT WAS REPORTED THAT THE SURGEON NOTICED THAT THE WHITE TIP OF THE GLENOSPHERE ORIENTATION GUIDE WAS CRACKED. STAFF OPENED ANOTHER SET AND PROCEEDED. THERE WAS NO DELAY IN SURGERY. ALL PARTS WERE RETAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22028015 ↗
• MalfunctionMay 12, 2025Break; Break

  IT WAS REPORTED THAT THE DELTA XTEND LOCKING GREEN SCREWDRIVER AND GLENOSPHERE ORIENTATION HANDLE WERE BROKEN. NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22002919 ↗
• MalfunctionMay 1, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE SURGEON HAD CHOSEN TO USE AN ECCENTRIC GLENOSPHERE SO AS PER SURGICAL TECHNIQUE OPTED TO USE THE GLENOSPHERE GUIDE WHEN SCREWING ON THE GLENOSPHERE TO GET THE ORIENTATION CORRECT. THE SURGEON HAD SOME DIFFICULTIES WITH THE MUSCLES BEING QUITE TIGHT IN THE AREA AND IT PROVED DIFFICULT SCREWING IN THE GLENOSPHERE. THE CONSULTANT NOTICED THAT THE SMALL METAL NIPPLE THAT IS ON THE END OF THE GUIDE HAD BROKEN OFF. THE SMALL PIECE OF METAL WAS NOT VISIBLE AND AT THAT POINT IT WASN¿T CLEAR WHETHER IT HAD BEEN TAKEN UP BY THE SUCTION OR WAS STILL INSIDE THE PATIENT. THE X-RAY TAKEN REVEALED THAT THE METAL PIECE WAS STILL INSIDE THE PATIENT AND HAD FALLEN SOMEWHERE DOWN THE ARM INTO THE MUSCLE. THE SURGEON DECIDED IT WOULD CAUSE MORE DAMAGE TO RETRIEVE THE PIECE OF METAL AND SO DECIDED TO LEAVE IT INSIDE THE PATIENT. X-RAY WAS TAKEN WHICH CAUSED 25-30 MINUTES OF DELAY TO THE PROCEDURE. THE HOSPITAL HAD TO OPEN ANOTHER ONE OF THEIR TRAYS TO GET AN IDENTICAL INSTRUMENT TO PROCEED WITH THE PROCEDURE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21945333 ↗
• MalfunctionApr 29, 2025Break; Break

  IT WAS REPORTED THAT ORIENTATION GUIDE WAS CRACKED/BROKEN UPON INSPECTION. ALL PIECES WERE RETRIEVED. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925134 ↗
• MalfunctionApr 22, 2025Break; Break

  IT WAS REPORTED THAT THE GLENOSHPERE ORIENTATION GUIDE TIP BROKE OFF IN SPD. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882635 ↗