TC-100 71170029Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010180681), received between Aug 12, 2020 and Dec 21, 2021 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionDec 17, 2020Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, SCREWDRIVER BROKE. INSTRUMENT WAS OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH & NEPHEW BACK-UP DEVICE. NO 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 11030886 ↗
• MalfunctionOct 8, 2020Break; Break

  IT WAS REPORTED THAT THE SCREWDRIVER HEX BROKE INSIDE THE DRILL GUIDE AND THE TIP OF THE SCREW DRIVER IS NOW MISSING. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10648092 ↗
• MalfunctionAug 12, 2020Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE THE TIP OF THE HEX DRIVER BROKE OFF OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. BACKUP FROM SMITH&NEPHEW WAS AVAILABLE. 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 Known Impact Or Consequence To Patient

  MAUDE report 10397027 ↗

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