NA DWD063Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 03700386931796), received between Dec 2, 2016 and Sep 26, 2025 — classified as 8 injuries, 7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, THE GUIDE WIRE WAS BROKEN UPON DRILLING IT IN PATIENT. THE ADDITIONAL MEDICAL INTERVENTION WAS NEEDED WITH THE USAGE OF BROKEN SCREW SET AND XRAY. LATER, THE X-RAY SHOWED NOTHING WAS LEFT IN PATIENT. THE LONGER ANESTHESIA AND OPERATING TIME WAS ALSO REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23154830 ↗
• InjuryAug 18, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, UNFORTUNATELY, THE GUIDE PIN (DWD063) WAS PLACED IN THE SHARPS BIN AND DISCARDED AS IT WAS BROKEN AND SHARP, RISKING INJURY IF SENT FOR STERILIZATION. THE MAJORITY OF THE WIRE CAME OUT WITH/INSIDE THE CENTRAL PEG DRILL (OTHER TWO INSTRUMENTS LISTED IN THE EMAIL), ONCE THE SURGEON HAD FINISHED WITH THAT STEP OF THE OPERATION. THIS WAS LEFT UNTIL THE END OF THE OPERATION TO TAKE APART AND IT WAS PRESUMED THAT THE WHOLE WIRE WAS INSIDE THE DRILL (AS HAPPENS IN OTHER OPERATIONS). IT WAS ONLY NOTICED THAT THE TIP OF THE GUIDE WIRE WAS MISSING DURING CLOSURE OF THE PATIENT, WITH THE SURGEON REQUESTING AN X-RAY TO CONFIRM THEIR SUSPICION, THAT THE TIP OF THE WIRE WAS STILL LOCATED IN THE SCAPULA OF THE PATIENT JUST BEHIND THE IMPLANT. NO OTHER MEDICAL INTERVENTION OCCURRED. ADDITIONAL INFORMATION: THE TIP OF THE GUIDE WIRE IS STILL INSIDE THE PATIENT LOOKS TO BE ENCASED IN THE SCAPULA DIRECTLY BEHIND THE GLENOID IMPLANT (WHICH IS CEMENTED IN POSITION). THE REST OF THE WIRE WAS DISCARDED AS IT WAS NOT VIABLE FOR STERILIZATION DUE TO ITS SHARP/BROKEN CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 22835151 ↗
• MalfunctionAug 1, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE PIN WAS BEING USED ON POWER AND SNAPPED OFF IN THE PATIENT. THE SURGEON HAD TO WORK TO GET THE BROKEN PIECE OUT AND ADDED TO THE CASE TIME.

  Patient problems: Insufficient Information

  MAUDE report 15139662 ↗
• MalfunctionMar 10, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A REVERSE SHOULDER ARTHROPLASTY, THE GLENOID GUIDEWIRE BROKE OFF AT THE DISTAL END WHEN DRILLING IN THE POST HOLE FOR THE GLENOID BASEPLATE. THE GUIDE WIRE TIP THAT BROKE OFF COULD NOT BE RETRIEVED FROM THE PATIENT. X-RAYS WERE TAKEN AND IT WAS REPORTED TO BE LOCATED IN SCAPULAR. THE SURGEON CONTINUED THE PROCEDURE TO COMPLETION.

  Patient problems: Foreign Body In Patient

  MAUDE report 13722221 ↗
• MalfunctionNov 2, 2021Fracture; Fracture

  CUSTOMER REPORTED US THE FOLLOWING INFORMATION: "DESCRIPTION OF INCIDENT: 71 YEARS OLD FEMALE PATIENT, 129KG, 168CM. DURING A RIGHT REVERSE TOTAL SHOULDER REPLACEMENT FOR SHOULDER OSTEOARTHRITIS, THE GUIDE WIRE BROKE IN THE PATIENT'S SHOULDER. A PART OF ABOUT 1CM REMAINED STUCK IN THE BONE. ACTION TAKEN: LENGTHENING OF THE PROCEDURE, IMPOSSIBILITY TO REMOVE THE ENTIRE GUIDE WIRE FROM THE SHOULDER. NO CLINICAL CONSEQUENCES FOR THE PATIENT". THE SURGICAL DELAY WAS 5 MINUTES LENGTH.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 12738400 ↗
• MalfunctionFeb 25, 2021Break; Break

  THE GUIDE WIRE WAS ADVANCED INTO THE GLENOID, THE SURGEON WANTED TO ADJUST THE PIN LOCATION AND BACKED OUT THE PIN. THE DISTAL TIP OF THE DWD063 GUIDE WIRE BROKE OFF RIGHT AT THE START OF THE THREADS. THE PIECE THAT BROKE OFF WAS LEFT IN THE SCAPULA AND COULD NOT BE RETRIEVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11377483 ↗
• InjuryJan 2, 2019Material Fragmentation; Material Fragmentation

  TIP OF THREADED PIN SNAPPED OFF INSIDE PATIENT'S GLENOID. NO IMPACT TO PATIENT. THE TIP WAS REMOVED UNDER X-RAY. (ADDITIONAL SURGICAL PROCEDURE REQUIRED).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8207829 ↗
• InjuryOct 30, 2018Material Fragmentation; Material Fragmentation

  DR (B)(6) PERFORMED A REVERSED SHOULDER REPLACEMENT WHICH WENT SMOOTHLY. UNFORTUNATELY DURING POST OPERATIVE X RAYS IT WAS FOUND THAT THE GUIDE WIRE HAD BROKEN AND A PIECE OF IT REMAINED IN THE PATIENTS SOFT TISSUE. A REVISION SURGERY WAS PERFORMED AFTER REVIEW OF THE POST-OP X-RAYS TO REMOVE THE PIN FRAGMENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8018773 ↗
• MalfunctionJul 18, 2018Material Fragmentation; Material Fragmentation

  TIP OF GUIDE PIN FOR AEQUALS GLENOID SNAPPED OFF. UNSURE IF IT IS IN THE PATIENT. (ID PATIENT (B)(4)).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7697721 ↗
• InjuryJan 26, 2018Material Deformation; Material Deformation

  THE TIP OF TORNIER DISPOSABLE GUIDE PIN BROKE. APPROXIMATELY 9 MM OF THE PIN REMAINED IN THE PATIENT. THE SURGEON WAS UNABLE TO RETRIEVE IT. IT WAS INTENTIONALLY LEFT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7221131 ↗
• InjuryJan 8, 2018Material Deformation; Material Deformation

  TIP OF GUIDE PIN BROKE OFF IN THE RIGHT GLENOID DURING TOTAL SHOULDER REPLACEMENT. PER SURGEON, IT DID NOT NEED TO BE REMOVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7171870 ↗
• InjuryDec 13, 2017Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  DURING DRILLING THE GLENOID CENTER HOLE, THE TIP OF GUIDE PIN BROKE OFF IN THE GLENOID BONE. THE SURGEON WAS ONLY ABLE TO RETRIEVE A PIECE OF THE BROKEN PIECES (THE TIP OF THE PIN HAD BEEN BROKEN INTO TWO PIECES.) ABOUT 1CM-LENGTH PIECE REMAINED IN THE PATIENT. THE RETRIEVED PORTION OF THE PIN HAS BEEN BLACKENED AND IT WAS NOT CERTAIN IF THE CANNULATED DRILL BIT HAD PROBLEMS. IT WILL BE RETURNED FOR ANALYSIS AS WELL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7112196 ↗
• InjuryJan 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2016: DURING SURGERY, GLENOID WAS FRACTURED. STEM AND HEAD WERE PLACED AND PHYSICIAN DECIDED TO WAIT ABOUT 6 MONTHS. (B)(6) 2016: WHEN THE PHYSICIAN REMOVED THE IMPLANTS TO REPLACE THEM ALL WITH COMPETITORS PRODUCTS, METALLOSIS WAS OBSERVED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6220924 ↗
• InjuryDec 16, 2016Material Deformation; Material Deformation

  IT WAS REPORTED THAT A GUIDE PIN BROKE DURING THE CASE. THE PIN WAS BEING PLACED TO REAM THE GLENOID FOR A PERFORM IMPLANT WHEN THE THREADED TIP OF THE WIRE BROKE OFF INSIDE THE GLENOID. THE BREAK CAUSED A MAJOR DELAY IN THE CASE AS THE SURGEON WAS TRYING TO REMOVE THE TIP.

  Patient problems: Device Embedded In Tissue or Plaque; Patient Problem/Medical Problem

  MAUDE report 6181242 ↗
• MalfunctionDec 2, 2016Material Deformation; Material Deformation

  IT WAS REPORTED THAT A BROCHE GUIDEPIN TIP (B)(4) BROKE DURING A RIGHT REVERSE TOTAL SHOULDER. AFTER MULTIPLE ATTEMPTS TO RETRIEVE IT, THE SURGEON ELECTED TO PROCEED WITH THE SURGERY LEAVING THE TIP EMBEDDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6140605 ↗