DELTA XTEND 2307-72-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295116080), received between Apr 23, 2018 and Apr 26, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2024Naturally Worn; Naturally Worn

  ITEM IS CROSS THREADED AND NEEDS REPLACING. IDENTIFIED IN STERILIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19193449 ↗
• MalfunctionJan 31, 2024Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE EVENT OCCURRED DURING THE PRE-OPERATIVE INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614308 ↗
• MalfunctionNov 15, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THERE WERE NO PATIENT CONSEQUENCES. IT ALSO STATES THAT THERE IS ONLY ONE REPORTED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18142779 ↗
• MalfunctionJan 10, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  BROKEN DELTO PEC CUTTING GUIDE FROM DELTA XTEND LOAN KIT - SMALL FIXED PIN WHICH STOPS THE CUTTING PLATE HOLDER FROM SLIDING OFF IS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16132242 ↗
• MalfunctionDec 3, 2021Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE THREAD ON THE DELTA PECTORAL, DELTA XTEND CUTTING GUIDE SCREW HAS CROSS THREADED WHICH MEANS WE COULDN'T SECURE IT TO THE INTERMEDULLARY GUIDE. THERE WAS A FIVE MINUTE SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 12924233 ↗
• MalfunctionNov 29, 2021Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED THAT THE THREADING ON THE CUTTING GUIDE WAS CROSS THREADED. WHEN TIGHTEN ON TO THE BAR, IT WOULD NOT THREAD ALL THE WAY. THE THREADING GOT STUCK AND WOULD NOT TIGHTEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12882374 ↗
• MalfunctionNov 16, 2021Naturally Worn; Naturally Worn

  INSTRUMENT DELTOPECTORAL CUTTING GUIDE FAULTY. GRUB SCREW IN THE SQUARE HOLE IS CROSS THREADED/STIFF/STUCK, NEEDS TO BE REPLACED. SURGICAL DELAY OF 2 MINUTES. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 12822033 ↗
• MalfunctionSep 20, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE PROCEDURE A SCREW BLOCKED WHILE RETRACTING THE DEVICE. IT HAPPENED DURING NORMAL USE. NO PATIENT CONSEQUENCE MENTIONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12497438 ↗
• MalfunctionMar 24, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DELTA XTEND REVERSE SHOULDER PROCEDURE: DELTOID PECTORAL CUTTING GUIDE WAS ATTACHED TO THE HANDLE FOR CUTTING GUIDE (INSTRUMENTATION AT THIS POINT WAS IN THE HUMERUS OF PATIENT) WHEN SURGEON TRIED TO REMOVE INSTRUMENTATION TO PROCEED, THE DELTOID PECTORAL GUIDE WOULD NOT DETACH FROM HANDLE AS PER SURGICAL TECHNIQUE THE TWO INSTRUMENTS FUSED TOGETHER. THE SURGEON SUBSEQUENTLY REMOVED BOTH INSTRUMENTS ATTACHED TO ONE ANOTHER USING A MALLET. SURGICAL DELAY 3 MINUTES AND PROCEDURE SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11561105 ↗
• MalfunctionMay 11, 2020Break; Dull, Blunt; Break; Dull, Blunt

  BLUNT DRILL BIT AND BROKEN DELTOPECTORAL CUTTING GUIDE ATTACHMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10044761 ↗
• MalfunctionMay 13, 2019Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT THE PIN FELL OUT CAUSING THE SCREW TO BE LOOSE. SAW BLADE WAS BROKEN. NO SURGICAL DELAY HAPPEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8605580 ↗
• MalfunctionMay 7, 2019Break; Component Missing; Break; Component Missing

  A SMALL PIECE OF METAL THAT RETAINS THE SLIDING PART OF THE JIG, CAME OFF, SO THAT THE JIG CAN BE SEPARATED INTO 2 COMPONENTS. SURGEON WAS CONFIDENT THAT THE METAL WAS NOT IN THE WOUND. ACTION TAKEN TO MANAGE THE PROBLEM: APPEARS IT CAME APART AFTER USE ON PATIENT. SURGEON INSPECTED THE WOUND FOR THE PIECE. WAS CONFIDENT THAT IT WAS NOT IN THE WOUND. NO DELAY IN SURGERY. NO ADVERSE OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8587650 ↗
• MalfunctionMay 2, 2019Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  THE BLUE TIGHTENING KNOB IS STRIPPED AND WILL NOT RELEASE. THE DEVICE NO LONGER CAN BE USED TO ALIGNMENT THE CUT. PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8575408 ↗
• MalfunctionApr 23, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SCREW ON THIS DEVICE HAS BECOME CROSS THREADED AT SOME POINT MAKING IT DIFFICULT TO USE. NOTHING ADVERSE HAPPENED TO THE PATIENT AND NO DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7450118 ↗