REFLECTION 71362292Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 03596010468253), received between Oct 30, 2019 and Jan 2, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

4 other recalls cover devices cleared under the same FDA submission (K121393); they may or may not involve this specific model.

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2025Fracture; Failure to Align; Fracture; Failure to Align

  IT WAS REPORTED THAT, DURING THR SURGERY, THE TIP OF THE DRIVER SHAFT OF A U-JOINT SCREWDRIVER WOULD NOT STAY PUT WITH THE SCREW ON IT. SURGEON COMPLAINED ABOUT NOT ALIGNING PROPERLY FOR IMPLANTATION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE. RESULTS OF INVESTIGATION HAVE CONCLUDE THAT THE DEVICE TIP WAS FRACTURED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21054741 ↗
• MalfunctionDec 30, 2024Break; Break

  IT WAS REPORTED THAT, DURING A THR, A (1) U-JOINT SCREWDRIVER BROKE WHEN LOCKING DOWN THE SCREW. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21036288 ↗
• MalfunctionDec 27, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, ONE (1) U-JOINT SCREWDRIVER BROKE WHEN LOCKING THE SCREW INTO THE R3 CUP. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21029606 ↗
• MalfunctionJan 24, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR A U-JOINT SCREWDRIVER BROKE OFF AT SWIVEL END DURING THE SCREW INSERTION. ALL THE BROKEN PIECES WERE REMOVED FROM THE WOUND AND ACCOUNTED. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18576218 ↗
• MalfunctionJan 18, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP OF A U-JOINT SCREWDRIVER BROKE WHILE TIGHTENING THE SCREW INTO THE CUP. THE DEVICE WAS REMOVED WITH THE SURGEON'S HAND, WASHED OUT THE WOUND TO REMOVE ANY DEBRIS AND SUCTION WAS USED TO FULLY CLEAN OUT THE WOUND. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16195792 ↗
• MalfunctionDec 27, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE SCREW WAS NOT STICKING ON THE U-JOINT SCREWDRIVER. IT WAS OBSERVED THAT THE TIP IS CHIPPED. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16055744 ↗
• MalfunctionFeb 10, 2022Break; Break

  IT WAS REPORTED THAT, DURING SET UP FOR A THR SURGERY, THE U-JOINT SCREWDRIVER WAS FOUND BROKEN BEFORE THE CASE. AS THIS WAS NOTICED UPON SET UP BEFORE THE PROCEDURE, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13510609 ↗
• MalfunctionJan 17, 2022Break; Break

  IT WAS REPORTED THAT, THE U-JOINT SCREWDRIVER WAS BROKEN. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13268117 ↗
• MalfunctionNov 17, 2021Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT A U-JOINT SCREWDRIVER CAME THROUGH THE WASH BROKEN. ARTICULATING HEAD HAS SEIZED UP. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12831828 ↗
• MalfunctionAug 4, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, A U-JOINT SCREWDRIVER BROKE WHILE INSTRUMENTS WERE OUTSIDE THE PATIENT. IT IS UNKNOWN IF ANY PIECE FELL INSIDE OF THE PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, USING A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12277352 ↗
• MalfunctionDec 9, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING THR PROCEDURE, THE U-JOINT SCREWDRIVER IS NOT HOLDING SCREW. THERE WAS NO DELAY AND THE SAME DEVICE WAS USED TO COMPLETE THE SURGERY. NO INJURIES REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10979579 ↗
• MalfunctionDec 3, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING SURGERY, THE TIP OF THE U-JOINT SCREWDRIVER SEEMED SLIGHTLY WORN. PROCEDURE CONCLUDED WITH THE SAME DEVICE, NO DELAY AND NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10938126 ↗
• MalfunctionAug 12, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE SCREWDRIVER IS WORN FROM EXCESSIVE USE AND NEEDS TO BE REPLACED. NO CASE INVOLVED, THEREFORE, NO PATIENT WAS HARMED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10399166 ↗
• MalfunctionOct 30, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE TIP OF THE SCREWDRIVER BROKE OFF WHILE SCREW TIGHTENING, IT BROKE INSIDE THE PATIENT, ALL PIECES WERE RECOVERED. S+N BACK-UP DEVICE AVAILABLE AND USED. DELAY GREATER THAN 30 MIN. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9258151 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121393. One submission often covers many models, so check the product and lot details in each record.

• Z-0878-2020 · Dec 16, 2019 · Open, Classified
  LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 714344
• Z-0200-2019 · Sep 18, 2018 · Terminated
  Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to mak
• Z-2163-2018 · May 4, 2018 · Terminated
  smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
• Z-1902-2018 · Apr 9, 2018 · Terminated
  smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System Components are indicated for rheumatoid arthritis; post-traumatic a