REFLECTION 71362293Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 03596010454188), received between Nov 20, 2019 and Oct 31, 2024 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (19 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE TIP OF ONE (X1) STRAIGHT SCREWDRIVER BROKEN OFF WHILE 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 20577968 ↗
• MalfunctionMar 4, 2022Break; Break

  IT WAS REPORTED THAT, THE STRAIGHT SCREWDRIVER WAS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13666486 ↗
• MalfunctionJul 9, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING A THR A STRAIGHT SCREWDRIVER WAS FOUND STRIPPED. SURGERY WAS FINISHED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12144613 ↗
• MalfunctionJun 16, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING THR SURGERY, A STRAIGHT SCREWDRIVER WAS NOTICED TO BE STRIPPED. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED TO OCCUR DUE TO THIS ISSUE, AS A SMITH AND NEPHEW BACKUP DEVICE WAS AVAILABLE. NEITHER PATIENT INJURY NOR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12012554 ↗
• MalfunctionJun 9, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A THR SURGERY, THE STRAIGHT SCREWDRIVER STRIPPED. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11963566 ↗
• InjuryMay 31, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A THR, THE STRAIGHT SCREWDRIVER WAS STRIPPED. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11909325 ↗
• MalfunctionMay 28, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING HIP SURGERY, THE STRAIGHT SCREWDRIVER STRIPPED. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE. NO INJURY TO PATIENT OR DELAY REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11903048 ↗
• MalfunctionMay 4, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE END OF THE STRAIGHT SCREWDRIVER IS STRIPPED. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11772861 ↗
• MalfunctionApr 21, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN OFFICE INSPECTION TWO STRAIGHT SCREWDRIVER HAD STRIPPED TIPS. NO CASE INVOLVED THEREFORE NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704463 ↗
• MalfunctionApr 21, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN OFFICE INSPECTION TWO STRAIGHT SCREWDRIVER HAD STRIPPED TIPS. NO CASE INVOLVED THEREFORE NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704462 ↗
• MalfunctionApr 11, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING THR SURGERY, WHILE USING THE STRAIGHT SCREWDRIVER INSIDE THE PATIENT, IT WAS NOTICED THAT THE DEVICE IS ROUNDED AT THE END DUE TO WEAR. THE PROCEDURE WAS FINISHED USING THE SAME DEVICE, WITHOUT SURGICAL DELAY AND NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646904 ↗
• MalfunctionApr 11, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT TWO R3 SCREWDRIVERS TIP ARE ROUNDED OFF AND WILL NOT ENGAGE PROPERLY. NO DELAY OR HARM REPORTED. THE EVENT WAS NOTICED OUTSIDE A SURGICAL ENVIRONMENT SINCE NO CASE WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646710 ↗
• MalfunctionMar 30, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT WHILE DOING INSTRUMENT INSPECTIONS IT WAS NOTICED THAT THE DRIVER WAS STRIPPED. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593385 ↗
• MalfunctionMar 14, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING OFFICE INSPECTION PROCESS, THE STRAIGHT SCREWDRIVER WAS NOTICED TO BE STRIPPED. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478832 ↗
• MalfunctionJan 27, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TIP ON SCREWDRIVER STRIPPED AND NEEDS REPLACEMENT. FAULT IN DEVICE WAS NOTICED UPON RETURN TO THE OFFICE ON CHECK-IN INSPECTION. NO EFFECT TO CUSTOMER OR CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11240552 ↗
• MalfunctionDec 30, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT, THE DOCTOR WAS USING THE STRAIGHT HEX DRIVER ON AN ACETABULAR SCREW & THE HEX SPUN OUT OF THE SCREW. AFTER INSPECTION IT WAS NOTICED THAT THE TIP OF THE STRAIGHT HEX DRIVER WAS WORN DOWN. THE PROCEDURE WAS COMPLETED WITH A MINIMAL DELAY USING A SMITH-NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11095896 ↗
• MalfunctionDec 24, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING INSPECTION IT WAS NOTICED THAT THE STRAIGHT SCREWDRIVER SHAFT HEX WAS ROUNDED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11072059 ↗
• MalfunctionOct 21, 2020Break; Break

  IT WAS REPORTED THAT SCREWDRIVER WAS FOUND BROKEN. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10714248 ↗
• MalfunctionOct 19, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE R3 SCREWDRIVER TIP IS ROUNDED OFF AND WILL NOT ENGAGE PROPERLY. NO DELAY OR HARM REPORTED. THE EVENT WAS NOTICED OUTSIDE A SURGICAL ENVIRONMENT SINCE NO CASE WAS INVOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10702665 ↗
• MalfunctionOct 19, 2020Defective Device; Naturally Worn; Defective Device; Naturally Worn

  IT WAS REPORTED THAT DURING EFIP INSPECTION THE STRAIGHT SCREWDRIVER WAS FOUND WITH A WORN OUT END. NO CASE RELATED THEREFORE NO PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10701802 ↗
• MalfunctionAug 28, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE END OF DRIVER WAS FOUND ROUNDED DURING SET UP OR INSPECTION. NO DELAY OR INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10469243 ↗
• MalfunctionAug 7, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE STRAIGHT SCREWDRIVER HEAD IS STRIPPED DUE TO USAGE. THIS WAS FOUND DURING SET UP / INSPECTION. NO SURGERY OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10378402 ↗
• MalfunctionAug 7, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE STRAIGHT SCREWDRIVER WAS FOUND TO BE STRIPPED. THIS WAS FOUND DURING SET UP / INSPECTION. NO SURGERY OR PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10378362 ↗
• MalfunctionNov 20, 2019Break; Break

  IT WAS REPORTED THAT DURING A THR PROCEDURE, THE TIP OF THE SCREWDRIVER BROKE OFF IN THE HEAD OF THE SCREW WHILE IMPLANTING THE CORTICAL SCREW. ALL THE PIECES WERE RETRIEVED, AND THE PROCEDURE PROCEEDED WITH THE FLEXIBLE SCREWDRIVER. THERE WERE NO DELAYS AND NO PATIENT INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9350113 ↗

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