DELTA XTEND 2307-74-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 182 adverse event reports that list this exact device (DI 10603295116134), received between Jul 10, 2017 and Apr 14, 2026 — classified as 1 injury, 181 malfunctions.

The most frequently reported specific device problem is “Break” (64 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 182 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 24875057 ↗
• MalfunctionOct 21, 2025Break; Break

  IT WAS REPORTED THAT INTRAOPERATIVELY THE INNER PART OF THE TRIAL STEM HOLDER BROKE OFF. NO ADVERSE PATIENT CONSEQUENCES, NO INSTRUMENT FRAGMENT REMAINED IN PATIENT. SURGERY WAS PROLONGED DUE TO THE DIFFICULT EXTRACTION OF THE TRIAL STEM.

  Patient problems: Insufficient Information

  MAUDE report 23349722 ↗
• 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 22642003 ↗
• MalfunctionApr 25, 2025Break; Break

  IT WAS REPORTED THAT THE INSERTER TIP WAS BROKEN OFF WHILE TRYING TO REMOVE REAMING GUIDE. IT DID NOT AFFECT PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21910858 ↗
• 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 21772734 ↗
• MalfunctionFeb 21, 2025Break; Material Deformation; Break; Material Deformation

  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 21432416 ↗
• MalfunctionDec 30, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT ARTHROPLASTY ON (B)(6) 2024. DURING THE PROCEDURE, THE INNER ROD FOR THE REAMER GUIDE BROKE INTO TWO PIECES. PROCEDURE WAS COMPLETED WITH FIVE MINUTES DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21039579 ↗
• MalfunctionOct 18, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE INSTRUMENT WAS REPORTED FOR AN UNKNOWN REASON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20480910 ↗
• MalfunctionOct 4, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? - YES B. WAS/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 20372659 ↗
• MalfunctionSep 25, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  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 20303056 ↗
• MalfunctionSep 3, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE TIP OF THE ROD IS BENT AND MAKING IT HARD TO SCREW INTO THE TIP OF THE HOLDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20125372 ↗
• MalfunctionJul 1, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE FRONT PART OF THE ROD FOR REAMING GUIDE HOLDER INSTRUMENT IS BENT AND WOULD NOT THREAD INTO THE HOLDER FOR REAMING GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19646125 ↗
• 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 18992667 ↗
• 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 18916816 ↗
• MalfunctionMar 12, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE HOLDER IS BENT. WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO PATIENT INVOLVEMENT, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18885491 ↗
• MalfunctionMar 11, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE HOLDER WAS BENT. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO PATIENT INVOLVEMENT, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874407 ↗
• MalfunctionMar 11, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE HOLDER IS BENT. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO PATIENT INVOLVEMENT, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874352 ↗
• 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 18857342 ↗
• MalfunctionFeb 27, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THIS WAS A REVERSE TOTAL SHOULDER JOINT REPLACEMENT FOR SHOULDER ROTATOR CUFF TEAR ARTHRITIS PERFORMED ON (B)(6) 2024. THE ROD FOR REAMING GUIDE HOLDER IN QUESTION WAS INSERTED INTO THE HOLDER FOR REAMING GUIDES, AND IT WAS ATTACHED TO THE PROXIMAL REAMING GUIDE 12 MM. THEN, IT WAS INSERTED INTO THE HUMERUS. AFTER REAMING THE PROXIMAL HUMERUS, THE SURGEON ATTACHED THE ROD AND THE HOLDER AND ATTEMPTED TO REMOVE THE PROXIMAL REAMING GUIDE. ALTHOUGH IT WAS CONNECTED TO THE PROXIMAL REAMING GUIDE BY TIGHTENING THE SCREWS IN THE ROD, IT WAS NOT INSTALLED PROPERLY. IT SLIPPED, AND THE PROXIMAL REAMING GUIDE COULD NOT BE REMOVED. THE ROD TIP WAS DEFORMED AND COULD NOT ATTACHED TO THE PROXIMAL REAMING GUIDE. THE SURGEON MANAGED TO EXTRACT THE PROXIMAL REAMING ROD BY USING PLIERS AND HITTING IT WITH A HAMMER. THE SURGEON PROCEEDED TO THE NEXT PROCEDURE, AND ALL IMPLANTS WERE INSERTED. THERE WERE NO BREAKAGES AND NO METAL FRAGMENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THERE WAS NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18787696 ↗
• MalfunctionNov 17, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? LESS THAN 1 MINUTE. B. DID IT BREAK INTO TWO OR MORE PIECES? IF NO, PLEASE SPECIFY THE ALLEGED DEFICIENCY OF THE INSTRUMENTS. WERE THEY BENT, STRIPPED, CROSS THREADED, ETC.? THE PRODUCT DID NOT BREAK DURING SURGERY. THE END OF THE STILUS WAS MISSING, WHICH FASTENS THE PROXIMAL PREP GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18160742 ↗
• MalfunctionNov 9, 2023Break; Break

  IT WAS REPORTED THAT THE PART ARRIVED BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18100035 ↗
• MalfunctionOct 27, 2023Break; Break

  IT WAS REPORTED THAT THE PROXIMAL REAMING GUIDE HOLDER INTERNAL ROD BROKE WHEN ATTACHING TO REMOVE. SURGICAL DELAY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18022970 ↗
• MalfunctionOct 26, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT WAS BENT AND WAS DIFFICULT TO LOOSEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18013035 ↗
• MalfunctionOct 23, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE TIP IS DAMAGED, SO YOU CANNOT LONGER SCREW THE DEVICE INTO THE REAMING GUIDES. NO IMPACT ON THE SURGERY NOR ON THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17986817 ↗
• MalfunctionOct 18, 2023Break; Break

  BOTH INSTRUMENTS BROKE DURING SURGERY, THE SURGEON WAS NOT DOING ANYTHING UNUSUAL, SAME TECHNIQUE AS ALWAYS. 230795000 HAD PLASTIC BREAK OFF WHILE INSERTING A GLENOSPHERE AND THE TIP OF 230774002 BROKE OFF WHILE TRYING TO ATTACH IT BACK ONTO THE PROXIMAL HUMERUS REAMING GUIDE - SINCE IT WAS BROKEN IT WAS NOT ABLE TO HOLD THE GUIDE AND AN ALTERNATE INSTRUMENT WAS NEEDED TO GET IT BACK OUT. PROCEDURE SUCCESSFULLY COMPLETED WITH A 5 MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17961357 ↗