DELTA XTEND 2307-87-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10603295116455), received between Jul 26, 2017 and May 27, 2026 — classified as 1 injury, 53 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (16 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 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT PRIOR TO THE START OF AN UNSPECIFIED PROCEDURE, THE 2.5MM K-WIRE COULD NOT BE GUIDED BY THE PLATE OF THE METAGLENES. THE DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25302383 ↗
• MalfunctionDec 10, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT DURING SURGERY WHEN DOING AN ANATOMIC GLOBAL ICON, WHEN USING THE DRILL ON THE METAGLENE GUIDE PIN DIA 2.5 MM, THE PIN GOT DAMAGED AS SEEN ON PICTURES. IT WAS EVEN A BIT OF METAL ON THE DRILL SHAFT AFTER EXTRACTING IT FROM THE GLENOID. THE METAL WAS VERY THIN, LIKE THE DRILL HAD SHAVED OF A BIT OF THE GUIDE PIN AS SEEN ON PICTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770791 ↗
• MalfunctionJan 2, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2024. THE SURGEON USED THE PLATE IN QUESTION AS NORMAL AND ATTEMPTED TO PASS A 2.5 MM METAGLENE GUIDE PIN THROUGH THE CENTRAL HOLE. HOWEVER, THE SURGEON FELT CAUGHT. THEREFORE, ONCE THE GUIDE PIN WAS REMOVED FROM THE PLATE IN QUESTION, IT WAS FOUND THAT THERE WERE MULTIPLE SCRATCHES WHEN LOOKING THROUGH THE CENTRAL HOLE. THE SURGEON DETERMINED THAT IT WAS NOT POSSIBLE TO USE A 2.5 MM METAGLENE GUIDE PIN TO PASS IT THROUGH, SO A 2.0 MM K-WIRE OWNED BY HOSPITAL WAS SUBSTITUTED. WITH THE SUBSTITUTION, THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WAS MORE THAN 30 MINUTES SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21063163 ↗
• MalfunctionNov 19, 2024Scratched Material; Scratched Material

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: B. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO. C. CAN YOU PLEASE CLARIFY WHAT DO YOU MEAN BY ¿DAMAGED¿? WAS IT WORN, CRACKED, BROKEN INTO PIECES, BENT, STRIPPED, CROSS THREADED OR ANY DEVICE INTERACTION. K-WIRES WERE WORN. D. WAS THERE ANY PATIENT HARM/CONSEQUENCE RELATED TO THE EVENT? NO.

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

  MAUDE report 20728579 ↗
• MalfunctionJul 21, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHILE TRYING TO POSITION THE METAGLENE GUIDE WIRE ON THE METAGLENE, THROUGH THE POSITIONING PLATE, THE WIRE GOT STUCK IN THE PLATE BEFORE IT WENT INTO THE BONE AND WOULDN¿T PROCEED TO BE INSERTED. THE STAFF CHANGED THE METAGLENE GUIDE WIRE AND THE SECOND ONE WENT THROUGH THE POSITIONING PLATE BUT REPORTEDLY FELT TIGHTER THAN USUAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370898 ↗
• MalfunctionJul 21, 2023Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT THE WIRES THAT ARE USED FOR METAGLENE PLACEMENT WERE TWISTED AND MADE IT IMPOSSIBLE FOR THE FINAL POSITIONING OF THE IMPLANT COMPROMISING THE SUCCESS OF THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370604 ↗
• MalfunctionJul 21, 2023Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT THE WIRES THAT ARE USED FOR METAGLENE PLACEMENT WERE TWISTED AND MADE IT IMPOSSIBLE FOR THE FINAL POSITIONING OF THE IMPLANT, COMPROMISING THE SUCCESS OF THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370603 ↗
• MalfunctionMay 17, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CENTRAL METAGLENE PIN GUIDE FELL OFF THE HANDLE. THIS GUIDE WOULD NOT ACCEPT THE GUIDE PIN. THE HOLE WAS TOO SMALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16947553 ↗
• MalfunctionMay 16, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DURING PLACEMENT OF METAGLENE CENTRAL GUIDE PIN ) THROUGH THE METAGLENE POSITIONER PLATE, THE REGISTRAR BENT THE GUIDE PIN ON BOTH THE FRONT SIDE AND BACK SIDE OF THE POSITIONER PLATE. SURGICAL TEAM WERE UNABLE TO REMOVE THE BENT PIN, AND THEREFORE RENDERED THE PLATE UNUSABLE. NO DELAY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16938681 ↗
• MalfunctionJan 31, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN INTO TWO PIECES. THE TIP STAYED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16272197 ↗
• MalfunctionJan 31, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN INTO TWO PIECES. THE TIP STAYED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16272195 ↗
• MalfunctionDec 7, 2022Device-Device Incompatibility; Device-Device Incompatibility

  INTROPERATIVELY, THE CENTRAL DRILL WAS INTRODUCED WITH THE PEG DRILL (7.5MM) OVER THE ALREADY LYING K-WIRE AND THE CENTRAL DRILL CHANNEL WAS PREPARED. WHEN THE DRILL WAS REMOVED, THE CENTRAL K-WIRE JAMMED IN THE DRILL AND COULD NO LONGER BE REMOVED. THE DRILL AND K-WIRE WERE REMOVED FROM THE PATIENT WITHOUT LEAVING ANY REMNANTS. THE REST OF THE SURGICAL PROCEDURE PROCEEDED AS PLANNED. NO PROLONGATION OF THE SURGERY TIME, NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15933737 ↗
• MalfunctionJul 19, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT BOTH ITEMS ARE BENT AND NEED REPLACING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15053837 ↗
• MalfunctionJul 19, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT BOTH ITEMS ARE BENT AND NEED REPLACING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15053824 ↗
• MalfunctionDec 14, 2021Device-Device Incompatibility; Device-Device Incompatibility

  LOT NUMBER UNKNOWN BUT WAS SENT BACK TO JNJ LOANS DEPARTMENT WITH THE REQUEST TO PULL THE SET FROM LOANS TEAM DUE TO THIS. IM SURE THE LOANS TEAM CAN NOW PROVIDE YOU WITH THIS LOT NUMBER. SURGICAL DELAY WAS APPROX. 5 MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13005774 ↗
• MalfunctionDec 14, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  THE METAGLENE GUIDE PIN GOT STUCK IN THE METAGLENE POSITIONING PLATE. IT SNAPPED OFF IN THE PLATE. THE STAFF WERE UNABLE TO REMOVE THE BROKEN SHARPE END FROM THE PLATE. ITS GONE OFF TO THEIR SSD DEPT AND IF THEY CANT REMOVE IT BE CAREFUL AS IT WILL COME BACK LIKE THAT TO US! THE 2ND METAGLENE GUIDE PIN GOT STUCK IN THE STOP DRILL AND ITS STILL IN THERE AS WELL SO BE CAREFUL WHEN IT COMES BACK. THE STOP DRILL WAS ALSO REPORTED AS BEING BLUNT. THE SURGEON WAS ABLE TO CONTINUE WITH THE CASE AND THANKFULLY WAS HAPPY WITH THE END RESULT OF THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13005361 ↗
• MalfunctionNov 30, 2021Break; Break

  IT WAS REPORTED THAT THIS WAS AN RSA FOR TREATING OMARTHRITIS DUE TO ROTATOR CUFF TEAR ON (B)(6) 2021. THE 2.5MM GUIDE PIN (UNK) DID NOT GO THROUGH THE POSITIONING PLATE BECAUSE IT WAS VERY TIGHT FOR THE GUIDE PIN TO PASS THROUGH THE POSITIONING PLATE¿S HOLE. A REPLACING GUIDE PIN WENT THROUGH THE POSITIONING PLATE WHICH RESULTED IN LESS THAN 30-MINUTE SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 12896495 ↗
• MalfunctionOct 1, 2021Material Deformation; Material Deformation

  TWO KIRSCHNER PINS WERE BENT. THEY COULDN'T BE USED IN THE OPERATING ROOM. THEY COULD COMPLETE THE PROCEDURE SUCCESSFULLY WITH A SURGICAL DELAY OF 5 MINUTES. THE SURGEON WAS UPSET AND NOT HAVING THESE PINS AVAILABLE WASN'T IDEAL FOR THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 12563123 ↗
• MalfunctionSep 30, 2021Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT THIS WAS AN ARTIFICIAL SHOULDER JOINT REPLACEMENT (LEFT SHOULDER) ON (B)(6) 2021. THE TWO GUIDE PINS DID NOT GO THROUGH THE PLATE. THEY POSTOPERATIVELY CONFIRMED THAT EVEN PASSING A K WIRE (2.4MM IN DIAMETER) THROUGH THE PLATE IN QUESTION WAS PRETTY TIGHT. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICES WERE BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12556159 ↗
• MalfunctionSep 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED THRU LOCAL LETTER TRANSLATED STATED THAT FOLLOWING: SUMMARY: RESULTS OF APPEARANCE INSPECTION, E. IN THE CASE OF THE PILOT-SCALE INSPECTION, BOTH THE PILOT-SCALE INSPECTION AND THE PIN-PASSING INSPECTION, BOTH OF THE PILOT-SCALE INSPECTION AND THE PIN-PASSING INSPECTION WERE RETURNED, BUT ONLY A SMALL PART OF THE TIP OF THE PIN PASSED, AND THE CONTENT OF THE COMPLAINT INFORMATION WAS REPRODUCED. E. IN THE MAGNIFIED APPEARANCE OBSERVATION OF SHONIN-GAF POINT, IT WAS OBSERVED THAT PART OF THE PORE WALL NEAR THE BACK SIDE OF THE PIN HOLE WAS PEELING FOR ABOUT HALF A CIRCUMFERENCE, AND THE PORE DIAMETER SEEMED TO BE NARROW. IN TERMS OF THE APPEARANCE OF THE PINS, THERE WERE SCRAPE MARKS, ABRASION MARKS, AND COMPRESSION MARKS IN 1 OF THE 2 PINS, AND A SLIGHT CURVATURE WAS OBSERVED. THIS PRODUCT WILL BE RETURNED TO THE OVERSEAS MANUFACTURER FOR FURTHER INVESTIGATION. IN JAPAN, WE WILL REVIEW THE INSPECTION ITEMS AT THE TIME OF LENDING. WE APOLOGIZE FOR ANY INCONVENIENCE THIS MAY HAVE CAUSED YOU. FIG. 1: ACCEPTED PRODUCTS: RECEIPT OF 1 POINT AT 7 ° RATE, MOSQUITO, KEMONATO, HIN, AND 2 POINTS, FIG. 2: 7 ° RATE MOSQUITO, MONITORING, PIN PASSING INSPECTION: IT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12556139 ↗
• MalfunctionSep 28, 2021Device-Device Incompatibility; Device-Device Incompatibility

  METAGLENE POSITIONER PLATE GOT STUCK ON THE METAGLENE DRILL PIN 2,5MM. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. ACTION TAKEN WHEN EVENT OCCURRED? DRILLED ON FREE HAND. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12541425 ↗
• MalfunctionSep 28, 2021Device-Device Incompatibility; Device-Device Incompatibility

  METAGLENE POSITIONER PLATE GOT STUCK ON THE METAGLENE DRILL PIN 2,5MM WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. ACTION TAKEN WHEN EVENT OCCURRED? DRILLED ON FREE HAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12541389 ↗
• MalfunctionSep 17, 2020Device-Device Incompatibility; Device-Device Incompatibility

  THE HOLE IN THE METAGLEN POSITIONER PLATE (230787003) WAS DEFECTIVE AND THE METAGLEN CENTRAL GUIDE PIN (230787004) COULD NOT BE INSERTED THROUGH IT. FOR THIS REASON, A 2.0MM WIRE FROM THE HOSPITAL HAD TO BE USED TO CONTINUE THE OPERATION.

  Patient problems: No Code Available

  MAUDE report 10549063 ↗
• MalfunctionApr 6, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THIS WAS A TSA (TOTAL SHOULDER ARTHROPLASTY) TREATING LEFT HUMERAL FRACTURE ON (B)(6) 2020. THE SURGEON PLACED THE POSITIONING PLATE (230787003) TO THE SCAPULAR JOINT AS PER SURGICAL TECHNIQUE. BUT S/HE WAS UNABLE TO INSERT A GUIDE PIN (230787004) INTO THE CENTRAL HOLE OF THE POSITIONING PLATE IN QUESTION. THE SURGEON MANUALLY INSERTED THE GUIDE PIN INTO THE JOINT AND COMPLETED THE PROCEDURE LESS THAN 30-MINUTE SURGICAL DELAY. THERE WAS NO HARM TO THE PATIENT. THE DEVICE WAS THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 9928995 ↗
• MalfunctionMar 26, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DELTA XTEND SURGERY - WANTED TO PLACE THE METAGLENE POSITIONING PLATE 2307-87-003 AND DRILL THE 2307-87-004 METAGLENE CENTRAL GUIDE PIN Ø 2.5 MM BY INSERTING IT THROUGH THE WHOLE OF THE PLATE. BUT THE PIN DIDN'T FIT THROUGH THE WHOLE.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 9882573 ↗