REFLECTION 71362295Recalls & reported problems

Summary

The FDA's MAUDE database contains 178 adverse event reports that list this exact device (DI 03596010454201), received between Feb 14, 2018 and May 31, 2026 — classified as 30 injuries, 148 malfunctions.

The most frequently reported specific device problem is “Break” (106 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 25 most recent of 178 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2026Break

  IT WAS REPORTED THAT, DURING A THA SURGERY, ONE (1) REF BALL JNT SCREWDRIVER SHAFT WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25342864 ↗
• MalfunctionMay 25, 2026Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, THE TIP OF ONE (1) REF BALL JNT SCREWDRIVER SHAFT BROKE OFF DUE TO TORSION. ALL BROKEN PIECES WERE ACCOUNTED FOR AND DID NOT FALL IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25273385 ↗
• MalfunctionMay 18, 2026Break

  IT WAS REPORTED THAT, DURING A THA SURGERY, THE TIP OF ONE (1) REF BALL JNT SCREWDRIVER SHAFT BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25203657 ↗
• MalfunctionMay 15, 2026Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP ON ONE REF BALL JNT SCREWDRIVER SHAFT BROKE OFF, ALL PIECES WERE ACCOUNTED FOR. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25185578 ↗
• MalfunctionMar 31, 2026Break

  IT WAS REPORTED THAT, DURING A THA SURGERY, TWO (2) REF BALL JNT SCREWDRIVER SHAFT BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24748122 ↗
• MalfunctionMar 7, 2026Fracture

  IT WAS REPORTED THAT DURING A THA, THE REF BALL JNT SCREWDRIVER SHAFT BROKE OFF WHEN INSERTING SCREW INTO 3 HOLE CUP. THE FRAGMENT DID FALL INTO THE PATIENT, BUT WAS REMOVED PROMPTLY BY HAND. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24540971 ↗
• MalfunctionFeb 4, 2026Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY ONE (1) REF BALL JNT SCREWDRIVER SHAFT SNAPPED AT THE END OF IT WHILE INSERTING A SCREW IN THE CUP. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257643 ↗
• MalfunctionFeb 3, 2026Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) REF BALL JNT SCREWDRIVER SHAFT BROKE WHILE PUTTING THE SCREW IN. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246689 ↗
• MalfunctionFeb 2, 2026Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, IT WAS NOTICED THAT THE BALL JOINT CONNECTION OF ONE (1) REF BALL JNT SCREWDRIVER SHAFT BROKE. NO PIECES FELL INSIDE THE WOUND. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24233094 ↗
• MalfunctionDec 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY ONE (1) REF BALL JNT SCREWDRIVER SHAFT BROKE WHEN THE SURGEON WAS REMOVING IT FROM THE LAST SCREW THAT NEEDED TO BE PUT IN. THE SCREWDRIVER WAS USED IN SURGERY TO PLACE TWO SCREWS AND WAS DISCOVERED TO BE BROKEN AFTER IT WAS FINISHED BEING USED WHILE SITTING ON THE BACK TABLE. NOTHING WAS LEFT ON THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23700186 ↗
• MalfunctionOct 24, 2025Break; Break

  IT WAS REPORTED THAT DURING A THA SURGERY, THE REF BALL JNT SCREWDRIVER SHAFT BROKE DURING SCREW INSERTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23381121 ↗
• MalfunctionJul 14, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, A REFLECTION BALL JOINT SCREWDRIVER SHAFT PIECE BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. IT IS UNKNOWN HOW WAS COMPLETED THE SURGERY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22493011 ↗
• MalfunctionMay 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THR THE ROTATING BALL TIP OF ONE (1) REF BALL JNT SCREWDRIVER SHAFT DISASSEMBLED WHEN THE PIN CAME OUT, NOTHING LEFT IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22024910 ↗
• MalfunctionApr 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) REF BALL JNT SCREWDRIVER SHAFT DISASSEMBLED WHILE INSERTING THE SCREW TO PATIENT¿S ACETABULUM. X-RAYS CONFIRMED THAT NO PIECES REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21851609 ↗
• MalfunctionMar 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT, A REF. BALL JNT SCREWDRIVER SHAFT BROKE WHILE INSERTING A SCREW, AND THE BROKEN MATERIAL FELL INTO THE CUP IN THE PATIENT. THE BROKEN PIECE WAS REMOVED USING TWEEZERS. THERE WAS NO SURGICAL DELAY, AND THE PROCEDURE WAS COMPLETED USING THE SAME FAULTY DEVICE. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21694974 ↗
• MalfunctionMar 6, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A THA SURGERY, ONE (1) REF BALL JNT SCREWDRIVER SHAFT WAS BROKEN BY SURGEON. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21542963 ↗
• MalfunctionFeb 24, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN R3 PROCEDURE, A (1) REF BALL JNT SCREWDRIVER SHAFT BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21445989 ↗
• MalfunctionFeb 13, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, THE TIP OF ONE (1) REF BALL JNT SCREWDRIVER SHAFT BROKE. IT IS UNKNOWN OF ANY PIECE FELL INSIDE THE INCISION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21375609 ↗
• MalfunctionJan 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, THE HEAD OF ONE [1] REF BALL JNT SCREWDRIVER SHAFT SNAPPED OFF WHILE SURGEON WAS PUTTING SCREW INTO CUP. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21217055 ↗
• MalfunctionJan 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, THE WORKING HEX END OF ONE (1) REF BALL JNT SCREWDRIVER SHAFT SNAPPED WHILE SCREWING IN THE SCREW. THE PIECES WERE RECOVERED AND DISCARDED APPROPRIATELY BY HOSPITAL STAFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124923 ↗
• MalfunctionDec 3, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A THR, A (1) REF BALL JNT SCREWDRIVER SHAFT BROKE WHEN PUTTING IN A SCREW. IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833343 ↗
• MalfunctionDec 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, ONE (1) REF BALL JNT SCREWDRIVER SHAFT WAS BROKEN ALONG WITH THE R3 VARIABLE ANGLE DRILL GUIDE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, OR IF IT CAUSED ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833145 ↗
• MalfunctionNov 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, THE BALL AT THE TOP OF ONE (1) REF BALL JNT SCREWDRIVER SHAFT BROKE OUT OF THE SOCKET. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. IT IS UNKNOWN IF THERE WAS A BACKUP DEVICE AVAILABLE NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20707498 ↗
• MalfunctionOct 31, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE TIP OF ONE (X1) REF BALL JNT SCREWDRIVER SHAFT BROKEN OFF WHEN INSERTING SCREW. NOTHING LEFT IN PATIENT. ALL PIECES RETRIEVED BY HAND. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20578111 ↗
• MalfunctionAug 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE TIP OF THE REF BALL JNT SCREWDRIVER SHAFT DEVICE GOT BROKEN. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, BUT IT IS UNKNOWN HOW. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19968468 ↗