DELTA XTEND 2307-83-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10603295116363), received between Jul 21, 2017 and Feb 19, 2025 — classified as 52 malfunctions.

The most frequently reported specific device problem is “Break” (42 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 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2025Break; Illegible Information; Break; Illegible Information

  IT WAS REPORTED THAT INTRAOPERATIVELY IT HAD NOT BEEN POSSIBLE TO USE THE INSTRUMENT AS A PART WAS LOOSENED FROM THE INSTRUMENT. THERE IS A PLATE ON THE INSTRUMENT'S TOP WHICH CAME OFF THE INSTRUMENT. IT DID NOT ENTER THE SURGICAL AREA. ANOTHER INSTRUMENT WAS AVAILABLE AND THE PROCEDURE WAS FINISHED WITHOUT ANY ISSUE AND WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THE LOT NUMBER ON THE DEVICE COULD NOT BE READ BECAUSE IT WAS FADED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21411560 ↗
• MalfunctionOct 9, 2024Break; Break

  IT WAS REPORTED THAT THIS WAS AN ARTIFICIAL JOINT REPLACEMENT FOR OSTEONECROSIS ON (B)(6) 2024. DURING TRIAL INSERTION WITH THE IMPLANT DRIVER IN QUESTION, A PART WAS REMOVED FROM THE PRODUCT AND THE GRASPING FUNCTION WAS BROKEN. THE SURGERY WAS PERFORMED WITHOUT USING THE IMPACT. THERE WAS A THIRTY MINUTES OF SURGICAL DELAY AND THERE WAS NO PATIENT HARM. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408692 ↗
• MalfunctionSep 19, 2024Break; Break

  PROCEDURE: DELTA TOTAL SHOULDER PROSTHESIS DURING THE IMPLANTATION OF DEFINITIVE IMPLANT (OF THE MONOBLOCK CEMENTED ROD), AT THE REMOVAL OF THE HANDLE OF THE HUMERAL IMPLANT HOLDER, THE IMPACTED DEVICE BROKE: THE ROUND PLATINUM PULLED OFF BECAUSE OF 4 BROKEN SCREWS AND 2 PULLED-OFF SQUARED PLATES. THE HANDLE BROKE DURING A NORMAL USE. NO DISCONTINUATION OF THE PROCEDURE. NO CHANGE OF THE SURGICAL TECHNIQUE. NO PATIENT CONSEQUENCE. THE IMPACTED DEVICE WAS IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20255255 ↗
• MalfunctionAug 26, 2024Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN. ALL PIECES WERE ACCOUNTED FOR AND NOTHING LEFT IN PATIENT. THERE WAS A TWO MINUTE DELAY TO OPEN ANOTHER INSTRUMENT PAN.

  Patient problems: Insufficient Information

  MAUDE report 20063407 ↗
• MalfunctionApr 29, 2024Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  THE DELTA XTEND IMPLANT HOLDER WAS NOT GRASPING THE IMPLANT VERY WELL AND NEEDS REPLACING. THE SURGEON REPORTS IT FELT LOOSE. IT CAUSED NO DETRIMENT TO THE PATIENT OR DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19209742 ↗
• MalfunctionApr 2, 2024Break; Break

  IT WAS REPORTED THAT DURING IMPLANTATION OF HUMERAL STEM THE INSERTION HANDLE FELL APART. THERE WAS NO HARM DONE TO PATIENT OR DELAY IN CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19028399 ↗
• MalfunctionMar 27, 2024Break; Break

  IT WAS REPORTED THAT THE BLUE BUTTON BROKE AFTER IMPLANTING FINAL PROSTHESIS. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18986977 ↗
• MalfunctionJan 25, 2024Break; Break

  IT WAS REPORTED THAT DEVICE WAS DEFECTIVE, NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18580059 ↗
• MalfunctionDec 20, 2023Break; Break

  IT WAS REPORTED THAT DEVICE BROKE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, 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 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 18367587 ↗
• MalfunctionOct 30, 2023Break; Break

  IT WAS REPORTED THAT THE LOCKING MECHANISM IS BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 18029281 ↗
• MalfunctionJun 22, 2023Unintended Movement; Unintended Movement

  PLEASE CAN I REPORT THE FOLLOWING 2 INSTRUMENTS WHICH NEED REPLACING AT (B)(6) HOSPITAL ON THEIR CONSIGNED DELTA TRAY. DATE REPORTED 16/06/2023. SURGEON MR (B)(6). SURGERY REVERSE SHOULDER REPLACEMENT. NO DELAY TO SURGERY ONLY TIME TAKEN TO OPEN THEIR SECOND SET OF INSTRUMENTS. NO HARM TO PATIENT. INSTRUMENTS NOT AVAILABLE TO RETURN. LOCKING SCREW DRIVER ONE OF THE 4 PRONGS AT THE TIP OF THE SCREW DRIVER MISSING. THIS WAS NOTED BEFORE USE IN THE CASE SO NOT USED ON PATIENT. ANOTHER SET OF INSTRUMENTS AVAILABLE AT THE HOSPITAL TO USE. IMPLANT HOLDER ¿ LOOSE ON TRIAL IMPLANT SO NEEDS REPLACING. ANOTHER SET AVAILABLE AT THE HOSPITALS SO WERE USED INSTEAD FOR THE CASE. NEITHER INSTRUMENTS AVAILABLE TO RETURN AT PRESENT UNTIL REPLACEMENTS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17187910 ↗
• MalfunctionApr 19, 2023Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773772 ↗
• MalfunctionApr 11, 2023Break; Break

  IT WAS REPORTED THAT THE HUMERAL IMPLANT DRIVER HAS A PART BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16711975 ↗
• MalfunctionMar 28, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED. STATES, THAT THE PIECE HAS 4 SCREWS ON THE SURFACE AND CAME BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16626880 ↗
• MalfunctionFeb 21, 2023Break; Break

  IT WAS REPORTED THE HANDLE IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16408938 ↗
• MalfunctionJan 5, 2023Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED BY THE THEATRE SISTER THAT THE EPIPHYSIS INTRODUCER ON ONE OF THEIR DELTA XTEND INSTRUMENT TRAYS IS BROKEN AND NEEDS REPLACEMENT DUE TO WEAR AND TEAR. THEY HAVE A SECOND INSTRUMENT TRAY THAT CAN BE USED SO NO IMPACT TO PATIENT CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16102192 ↗
• MalfunctionJan 4, 2023Break; Break

  IT WAS REPORTED THE DEVICE BROKE DURING THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16096915 ↗
• MalfunctionDec 13, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON NOVEMBER 29, 2022. WHEN THE SURGEON TRIED TO REMOVE THE STEM TRIAL FROM THE IMPLANT DRIVER, THE SURGEON FELT THAT THE IMPLANT DRIVER WAS STUCK, AND THE IMPLANT DRIVER DID NOT COME OFF. THE CONNECTED TIP OF THE IMPLANT DRIVER BROKE WHEN THE SURGEON TRIED TO DETACH THE IMPLANT DRIVER FROM THE STEM TRIAL AGAIN. THE SURGERY WAS COMPLETED WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15969134 ↗
• MalfunctionDec 7, 2022Break; Break

  ADDITIONAL INFORMATION RECEIVED: A. WHAT PART OF THE HUMERAL IMPLANT DRIVER BROKE? THE CONNECTION ZONE WITH THE STEM. B. DID IT BREAK INTO TWO OR MORE PIECES? IF NO, PLEASE SPECIFY WHAT IS THE ALLEGED DEFICIENCY, IS IT BENT, CRACKED, STRIPPED, SCRATCHED, WORN OR CROSS-THREADED? YES. C. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO.

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

  MAUDE report 15935001 ↗
• MalfunctionNov 17, 2022Break; Break

  IT WAS REPORTED THAT THE DEVICE BROKE. NO DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15818356 ↗
• MalfunctionNov 4, 2022Break; Break

  IT WAS REPORTED THAT INTRAOPERATIVELY THE INSTRUMENT´S INNER SPRING FRACTURED INTO TWO OR MORE PARTS. NO ADVERSE PATIENT CONSEQUENCES, NO SURGICAL DELAY. SURGERY WAS COMPLETED SUCCESSFULLY, NO FRAGMENT ENTERED SURGICAL AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15726824 ↗
• MalfunctionOct 31, 2022Break; Break

  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 15698984 ↗
• MalfunctionJun 16, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SCREW AND THE INTRODUCER SPRING BROKE AND THE INTRODUCER DID NOT HOLD THE TEST ROD AND THE FINAL ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14713714 ↗
• MalfunctionJun 15, 2022Break; Break

  THE TWO INSTRUMENTS BROKE DURING SURGERY. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14697229 ↗
• MalfunctionJun 2, 2022Break; Break

  DEVICE BROKE DURING THE SURGERY, SEE ENCLOSED PICTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14577432 ↗