DELTA XTEND 2307-74-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 10603295116127), received between Aug 17, 2017 and Apr 14, 2026 — classified as 1 injury, 79 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (26 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 80 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Break; Mechanical Jam

  IT WAS REPORTED THAT A JAMMED INSTRUMENT CAUSED A PART TO BREAK OFF INTRAOPERATIVELY. THE EVENT RESULTED IN MINOR BONE DEFECTS DUE TO THE USE OF FOREIGN INSTRUMENTS TO REMOVE THE REAMING GUIDE FROM THE DISTAL BONE. THERE WAS A SIGNIFICANT DELAY IN THE PROCEDURE, BUT NO REPORTED PATIENT OR USER HARM.

  Patient problems: Bone Notching

  MAUDE report 24875137 ↗
• MalfunctionApr 1, 2026Break

  IT WAS REPORTED THAT THE THREADED HANDLE WAS BROKEN WHILE INSERTING STEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24755139 ↗
• MalfunctionJul 29, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE REAMING GUIDE HANDLE WAS NOT SCREWING IN PROPERLY AND WAS NOT LOCKING INTO REAMER. THERE WAS NO SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22641925 ↗
• MalfunctionApr 4, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE SURGEON WAS PERFORMING RIGHT REVERSE SHOULDER REPLACEMENT USING THE DELTA XTEND INSTRUMENTS. THE PROXIMAL REAMING GUIDE HOLDER AND REAMING GUIDE ROD WERE VERY DIFFICULT TO PUT TOGETHER. THE INTERNAL THREADS WERE DAMAGED CAUSING IT TO CROSS THREAD. THERE WAS NO SURGICAL DELAY. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21772705 ↗
• MalfunctionFeb 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  PLEASE CONFIRM IF THERE IS ANY ALLEGATION AGAINST THE 2 UNK INSERTION DEVICES AS PER SALES REP THE ANSWER IS "NO".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432365 ↗
• MalfunctionDec 10, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT 52 APG TRIAL WAS BROKEN. EPI BROACH HANDLE BECAME LOOSE. SURGICAL DELAY IS UNKNOWN. NO ADDITIONAL INFORMATION TO REPORT.

  Patient problems: Insufficient Information

  MAUDE report 20895794 ↗
• MalfunctionNov 7, 2024Break; Break

  IT WAS REPORTED THAT WHEN USING/ AND OR REMOVING THE EPI REAMING RETAINING BROACH, THE TIP WAS BROKE. NO ADDITIONAL INFORMATION TO REPORT.

  Patient problems: Insufficient Information

  MAUDE report 20630292 ↗
• MalfunctionOct 21, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON OCTOBER 8, THERE WAS BREAKAGE OF A SHOULDER INSTRUMENT IN THEATRE. WHEN INSERTING THE ¿PROXIMAL REAMER GUIDE¿ FULLY ASSEMBLED, THE PROXIMAL REAMER GUIDE INTERNAL ROD END / STRIKE PLATE SHEARED OFF AND COLD WELDED INTO THE PROXIMAL REAMER BODY. THE DEVICES COULD NOT BE SEPARATED. THE SALES REPRESENTATIVE ACQUIRED A BACKUP SET TO CONTINUE THE OPERATION WHICH CAUSED A SURGICAL DELAY OF LESS THAN ONE (1) MINUTE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20493131 ↗
• MalfunctionOct 11, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE LEVER OF THE HANDLE WAS LOOSE. UNKNOWN SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 20427863 ↗
• MalfunctionSep 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON SEPTEMBER 18, 2024 THAT THE TRIAL INSERTER WAS BENT AND WOULD NOT ADEQUATELY LOCK ONTO TO TRIAL. THE SCREWDRIVER WAS BEGINNING TO ROUND OFF IN SCREW HEAD.

  Patient problems: Insufficient Information

  MAUDE report 20303009 ↗
• MalfunctionAug 13, 2024Break; Break

  IT WAS REPORTED THAT WHEN IMPACTING THE PROXIMAL REAMING GUIDE, THE TOP OF THE INSERTER SHAFT BROKE OFF LEAVING THE GUIDE STILL THREADED WITHIN THE STEM.

  Patient problems: Insufficient Information

  MAUDE report 19971509 ↗
• MalfunctionMar 28, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  INTRAOPERATIVELY THE BOTH INSTRUMENTS GOT JAMMED AND THE THREADS BENT. SURGERY WAS FINISHED WITHOUT ANY DELAY AND WITHOUT ANY ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19000087 ↗
• MalfunctionMar 15, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  PROXIMAL REAMING GUIDE HOLDER INTERNAL ROD IS BENT - DIFFICULT TO SCREW INTO THE PROXIMAL REAMING GUIDE HOLDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18916812 ↗
• MalfunctionMar 7, 2024Break; Break

  IT LOOKS LIKE THE TIP OF ROD FOR REAMING GUIDE HOLDER HAS SNAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18857359 ↗
• MalfunctionNov 27, 2023Structural Problem; Material Integrity Problem; Structural Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE INSTRUMENT WAS DAMAGED AND DID NOT FUNCTION AS DESIGNED, INNER PORTION WOULD NOT SCREW COMPLETELY INTO HUMERAL PREP HANDLE. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18208453 ↗
• MalfunctionOct 12, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE THREADED INTERNAL ROD BENT AND COULD NOT EXTRACT PROXIMAL REAMING BODY. NOSURGICAL DELAY WAS THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17920916 ↗
• MalfunctionJul 13, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON MALLETED THE PROXIMAL HUMERAL REAMING GUIDE INTO THE HUMERUS AND THE THREADED TOP PIECE BROKE OFF. PATIENT WAS NOT HARMED AND THERE WERE NO FRACTURES. THE REMAINING INSTRUMENTATION WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17319701 ↗
• MalfunctionMay 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  INTRAOPERATIVELY BOTH INSTRUMENTS GOT JAMMED DURING USE. A SURGICAL DELAY WAS NOT REPORTED. NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16976469 ↗
• MalfunctionMay 11, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSTRUMENTS BROKE DURING SURGERY AND STUCK TOGETHER. CAN NOT TAKE APART. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16910779 ↗
• MalfunctionApr 18, 2023Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT THE INTERNAL ROD CROSS THREADED AND BENT INSIDE GUIDE HOLDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16761351 ↗
• MalfunctionOct 31, 2022Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  ADDITIONAL INFORMATION RECEIVED. A. WERE THE DEVICES AVAILABLE FOR RETURN? -> YES B. DID IT BREAK INTO 2 OR MORE PIECES? -> YES, IT FRACTURED INTO MORE PIECES C. DID THE EVENT OCCUR DURING THE SURGERY? IF YES, WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? -> ABOUT 5 MINUTES AS ANOTHER SET WAS OPENED/USED D.WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? -> NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698981 ↗
• MalfunctionAug 3, 2022Break; Break

  IT WAS REPORTED THAT THE BLUE HANDLE DETACHED FROM GUIDE DURING IMPACTION. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15157517 ↗
• MalfunctionJul 6, 2022Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  THE ROD BROKE INTO TWO PIECES WHEN ATTACHED TO THE REAMER GUIDE. THE REAMER GUIDE SIZE 10 IS ATTACHED TO THE INSTRUMENT. A SMALLER REAMER GUIDE WAS USED TO CONTINUE REAMING. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14936422 ↗
• MalfunctionJun 20, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PROXIMAL REAMING GUIDE HOLDER INTERNAL ROD GOT STUCK INSIDE PROXIMAL REAMING GUIDE HOLDER AND WAS UNABLE TO BE REMOVED OR COMPLETELY ADVANCED SO WAS UNABLE TO BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14743625 ↗
• MalfunctionJun 17, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AFTER USING THE PROXIMAL REAMER GUIDE INSERTER, IT WAS NOTED THAT THERE WAS A LOOSE SPOT ALONG THE SIDE OF THE BASE. THERE ARE 2 OVAL AREAS WITH SQUIGGLY OUTLINES THAT ARE TYPICALLY FLUSH WITH THE SIDE OF THE INSERTER. ONE OF THEM WAS LOOSE AND ABLE TO WIGGLE AROUND, AND POP OUT AT AN ANGLE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14734905 ↗