TC-100 71170133Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010181329), received between Aug 10, 2020 and Jan 15, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2021Break

  IT WAS REPORTED THAT A HEX SCREWDRIVER LARGE WAS FOUND TO BE BROKEN, THE END OF THE SCREWDRIVER SHEARED. IT WAS PUT DOWN TO STANDARD WEAR AND TEAR AS IT HAD BEEN USED FOR QUITE SOME TIME. IT IS UNKNOWN WHEN WAS THIS MALFUNCTION DISCOVERED AND IF THERE WAS A DELAY OR A BACK UP WAS NEEDED. NO INJURIES REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11181249 ↗
• MalfunctionJan 14, 2021Crack; Crack

  IT WAS REPORTED THAT WHILE DOING PRE-CHECKS BEFORE A HARDWARE REMOVAL CASE, IT WAS NOTICED THAT THE HEX SCREWDRIVER LARGE IS WARPED/ CRACKED AND IS UNABLE TO USE IT. A S&N BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS A DELAY OF LESS THAN 30 MIN. NO INJURIES REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11168563 ↗
• InjuryAug 10, 2020Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HOSPITAL PURCHASED 3 X LARGE FRAG SCREWDRIVERS, BUT ONE OF THE SCREWDRIVERS SNAPPED DURING THE REMOVAL OF METAL-WARE (THIS OCCURRED OUTSIDE THE PATIENT). THE PROCEDURE HAD A DELAY BETWEEN 0-30 MIN. BACKUP FROM SMITH&NEPHEW WAS AVAILABLE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. THE HOSPITAL WANTS A FREE REPLACEMENT. THE HEALTH OF PATIENT IS UNKNOWN. THE SURGEON BLAMES THE DEVICE

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 10388021 ↗

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