CHS 115035Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 03596010052063), received between Jan 30, 2019 and Sep 5, 2023 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING TKA SURGERY, THE TIP OF ONE (X1) HEX SCREWDRIVER BROKE OFF DURING USE INSIDE THE WOUND WHILE ADJUSTING THE FEMORAL SIZER. THE PIECE WAS LOCATED AND REMOVED FROM THE FIELD. THE PROCEDURE WAS COMPLETED WITHOUT DELAY WITH A SMITH AND NEPHEW BACKUP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17683412 ↗
• MalfunctionFeb 4, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE TIP OF A HEX SCREWDRIVER BROKE OFF WHILE USING TO ADJUST THE AP SIZER. THE BROKEN TIP STAYED IN SIZER AND DID NOT FALL IN PATIENT. 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 16301814 ↗
• MalfunctionApr 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A HEX SCREWDRIVER FOR 4.5MM AND 6.5MM BONE SCREWS DETACHED FROM HANDLE. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14075167 ↗
• MalfunctionFeb 24, 2022Break; Unintended Movement; Break; Unintended Movement

  IT WAS REPORTED THAT A HEX SCREWDRIVER WAS NOTICED TO BE BROKEN AND IT IS FREELY ROTATING. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13593903 ↗
• MalfunctionJan 26, 2022Break; Break

  IT WAS REPORTED THAT , THE TIP OF THE HEX SCREWDRIVER BROKE. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13353801 ↗
• MalfunctionOct 12, 2021Break; Break

  IT WAS REPORTED THAT A HEX SCREWDRIVER FOR 4.5 MM AND 6.5 MM BONE SCREWS IS BROKEN. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12616120 ↗
• MalfunctionJul 12, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE END OF A HEX SCREWDRIVER WAS STRIPPED. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12155371 ↗
• MalfunctionJul 7, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, DURING THE SET UP FOR A TKA SURGERY, A HEX SCREWDRIVER SHAFT HAD COME LOOSE FROM THE HANDLE. THE SURGERY WAS COMPLETED WITHOUT ANY DELAY, USING A BACKUP DEVICE,. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12132340 ↗
• MalfunctionMay 31, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING TKA SURGERY, TWO GII QUICK CONNECT HANDLE WILL NO LONGER ENGAGE AND THE HEX SCREWDRIVER IS STRIPPED OUT. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO INJURY TO PATIENT OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11909328 ↗
• MalfunctionMay 27, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING TKA THE THREADS OF THE HEX SCREWDRIVER WAS STRIPPED. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO INJURY TO PATIENT OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11896277 ↗
• MalfunctionMay 21, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING SET UP FOR A TKA, THE END OF 2 HEX DRIVER (ADDED FOR MIS SIZING GUIDE A) WERE ROUNDED OFF. 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 11862654 ↗
• MalfunctionMay 21, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING SET UP FOR A TKA, THE END OF 2 HEX DRIVER (ADDED FOR MIS SIZING GUIDE WERE ROUNDED OFF. 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 11862531 ↗
• MalfunctionFeb 19, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING TKA PROCEDURE THE SHAFT OF SCREWDRIVER NOTICED TO BE SPINNING WITHIN THE HANDLE. SEVERAL ATTEMPTS MADE TO ADJUST 2 AND 4MM OFFSET COUPLER TRIALS WITH NO SUCCESS. THE PROCEDURE WAS COMPLETED WITH LESS THAN 30 MINUTES DELAYED WITH AN SMITH&NEPHEW BACKUP DEVICE. NO PATIENT HARM OR ADDITIONAL COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11347222 ↗
• MalfunctionNov 5, 2019Break; Break

  IT WAS REPORTED THAT THE HEX DRIVER BROKE WHILE THE SURGEON WAS TRYING TO TIGHTEN DOWN TIBIAL CUTTING BLOCK. NO DELAY REPORTED. NO PATIENT INJURIES REPORTED. AN S&N BACKUP WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9282386 ↗
• MalfunctionMay 8, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING THE CASE, SURGEON TRIED MAKING AN ADJUSTMENT TO THE 5-IN-1 CUTTING BLOCK AND THE HANDLE WAS SPINNING OUT, NOT GRIPPING THE SCREWDRIVER. A COMPETITOR SYNTHES UNIVERSAL SCREWDRIVER WAS USED IN LIEU AND THE CASE WAS COMPLETED WITHOUT ANY HARM OR DELAY INVOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8592161 ↗
• MalfunctionJan 30, 2019Break; Break

  IT WAS REPORTED THAT THE SURGEON STATES THAT THE SCREWDRIVER BROKE DURING SURGERY. NO PIECES FELL INTO THE SURGICAL FIELD. SMITH AND NEPHEW BACKUP WAS USED. THERE WAS NO DELAY TO THE PROCEDURE, AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8290914 ↗

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