TC-100Recalls & reported problems across all models

We found 20 models of TC-100 by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 58 adverse event reports in the FDA's MAUDE database, received between Apr 9, 2018 and Feb 18, 2026 — classified as 1 death, 10 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Break” (25 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported TC-100 problems

TC-100 models

20 models, most reported first. Each model has its own page with its reports, recalls and device details.

• TC-100 71170047

  Prosthesis, hip, femoral component, cemented, metal
  17 reports
• TC-100 71170183

  Prosthesis, hip, femoral component, cemented, metal
  10 reports
• TC-100 71170029

  PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
  6 reports
• TC-100 71170033

  SCREWDRIVER
  3 reports
• TC-100 71170043

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  3 reports
• TC-100 71170133

  PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
  3 reports
• TC-100 71170036

  SCREWDRIVER
  2 reports
• TC-100 71176032

  PLATE, FIXATION, BONE
  2 reports
• TC-100 71170015

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  1 report
• TC-100 71170025

  PLATE, FIXATION, BONE
  1 report
• TC-100 71170034

  PLATE, FIXATION, BONE
  1 report
• TC-100 71170050

  Prosthesis, hip, femoral component, cemented, metal
  1 report
• TC-100 71170076

  PLATE, FIXATION, BONE
  1 report
• TC-100 71170149

  Plate, fixation, bone
  1 report
• TC-100 71170165

  PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
  1 report
• TC-100 71170169

  SCREWDRIVER
  1 report
• TC-100 71176021

  PLATE, FIXATION, BONE
  1 death1 report
• TC-100 71176026

  PLATE, FIXATION, BONE
  1 report
• TC-100 3571149740

  PLATE, FIXATION, BONE
  1 report
• TC-100 71143107

  PLATE, FIXATION, BONE
  1 report

Recent TC-100 adverse event reports

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

• MalfunctionFeb 18, 2026Fracture

  IT WAS REPORTED THAT, DURING OSTEOSYNTHESIS, WHILE RELEASING THE BONE CALLUS, THE TIP OF ONE (1) SHARP HOOK BECAME LODGED AND BROKE OFF. THE ENTIRE PIECE WAS SUCCESSFULLY REMOVED WITH KELLY FORCEPS, BUT THE TIP FELL TO THE FLOOR AND WAS LOST; THE TIP COULD NOT BE FOUND. 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 24379317 ↗
• MalfunctionOct 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ORIF DISTAL HUMERUS CASE, THE PLATE CUTTING FORCEPS BROKE NEAR HINGE WHILE CUTTING A 2.7 Y PLATE. THE PROCEDURE WAS RESUMED, 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 20446472 ↗
• MalfunctionAug 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE, THE PLATE CUTTING FORCEPS BROKE. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. SURGERY WAS PERFORMED AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19999439 ↗
• InjuryMay 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION PROCEDURE, WHEN DRILLING THE LAST HOLE FOR A PLATE, THE 2.5 DRILL BIT {} QC 180/155 GOLD BROKE. PART OF THE BROKEN INSTRUMENT WAS LEFT INSIDE THE PATIENT, FLUSH TO THE BONE AND WILL NOT BE REMOVED. THE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19260059 ↗
• MalfunctionJun 5, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TIBIA OSTEOSYNTHESIS PROCEDURE, WHEN LOCKING SCREWS WITH A HEX SCREWDRIVER SHAFT UPON THE SECOND TURN OF THE SCREW, THE HEAD BROKE OFF. THE PROCEDURE WAS PERFORMED, 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 17062136 ↗
• MalfunctionOct 14, 2022Break; Break

  IT WAS REPORTED THAT A SHARP HOOK IS BROKEN. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15611013 ↗
• MalfunctionSep 21, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE END OF THE SHARP HOOK BROKE OFF IN USE, NO PIECE WAS LEFT IN THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15461730 ↗
• MalfunctionSep 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BENDING PLIERS FOR 2.7MM AND 3.5MM PLATES SEEMS TO BE MISSING A WASHER FOR THE BOLT LOCATED IN THE MIDDLE OF THE PLIERS. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15411554 ↗
• InjuryApr 28, 2022Break; Break

  IT WAS REPORTED THAT, WHEN SURGEON COMMENCED DRILLING DURING A TKA SURGERY, THE DRILL BIT LONG 4.5MM QC BROKE. INCIDENT OCCURRED INSIDE PATIENT, AND THE BROKEN PIECE WAS RETRIEVED. SURGERY WAS RESUMED, WITH A NON SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED BEYOND THE ISSUE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14246862 ↗
• MalfunctionDec 21, 2021Break; Break

  IT WAS REPORTED THAT, DURING SET-UP/INSPECTION FOR A TRAUMA SURGERY, IT WAS OBSERVED THAT THE TIPS OF TWO (2) SMALL HEX SCREWDRIVERS HAD BROKEN OFF OF THE INSTRUMENTS. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE INSTEAD. SINCE INCIDENT OCCURRED BEFORE PROCEDURE, PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13057781 ↗
• MalfunctionDec 21, 2021Break; Break

  IT WAS REPORTED THAT, DURING SET-UP/INSPECTION FOR A TRAUMA SURGERY, IT WAS OBSERVED THAT THE TIPS OF TWO (2) SMALL HEX SCREWDRIVERS HAD BROKEN OFF OF THE INSTRUMENTS. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A (B)(4) BACK-UP DEVICE INSTEAD. SINCE INCIDENT OCCURRED BEFORE PROCEDURE, PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13057774 ↗
• InjuryOct 20, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF A SMALL HEX SCREWDRIVER BROKE OFF IN THE PATIENT AND WAS RETRIEVED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12666247 ↗
• InjuryOct 20, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF A HEX SCREWDRIVER SHAFT BROKE OFF WHILE THE SURGEON WAS ATTEMPTING TO BEND PLATE. ALL PIECES WERE RECOVERED FROM THE PATIENT. SURGERY WAS COMPLETED WITH A BACKUP DEVICE, WITHOUT ANY DELAY. NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12666068 ↗
• MalfunctionSep 22, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING THE SET UP FOR A THR, IT WAS NOTICED THAT A 3.2 DRILL BIT QC 145/120 HAD PERFORATED THE STERILE PACKAGING, IT IS APPARENT THE BLACK PLASTIC INSERTS HAD DISLODGED FROM THE CLEAR PLASTIC TUBE RESULTING IN THE SHARP TIP OF THE DRILL PERFORATING THE STERILE OUTER PACKAGING. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12511111 ↗
• MalfunctionSep 22, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING THE SET UP FOR A THR, IT WAS NOTICED THAT A 3.2 DRILL BIT QC 145/120 HAD PERFORATED THE STERILE PACKAGING, IT IS APPARENT THE BLACK PLASTIC INSERTS HAD DISLODGED FROM THE CLEAR PLASTIC TUBE RESULTING IN THE SHARP TIP OF THE DRILL PERFORATING THE STERILE OUTER PACKAGING. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12511110 ↗

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