TC-100 71170047Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 03596010180803), received between Aug 14, 2020 and Oct 14, 2024 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (13 reports).

2 other recalls cover devices cleared under the same FDA submission (K123598); 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionAug 26, 2021Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT A PLATE CUTTING FORCEPS IS STIFF AND DOES NOT RE-OPEN AFTER USE, ALSO THE CUTTING BLADES ARE CHIPPED. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12374645 ↗
• MalfunctionJul 12, 2021Break; Break

  IT WAS REPORTED THAT A PLATE CUTTING FORCEPS 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 12151275 ↗
• MalfunctionMay 13, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT, THE PLATE CUTTING FORCEPS WERE DULL DURING A PLATE CASE. INSTRUMENT OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11817201 ↗
• MalfunctionApr 22, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING INSPECTION IT WAS NOTICED THAT 4 PLATE CUTTING FORCEPS WERE DULLED. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11711140 ↗
• MalfunctionApr 22, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING INSPECTION IT WAS NOTICED THAT 4 PLATE CUTTING FORCEPS WERE DULLED. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11711136 ↗
• MalfunctionApr 22, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING INSPECTION IT WAS NOTICED THAT 4 PLATE CUTTING FORCEPS WERE DULLED. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11711124 ↗
• MalfunctionApr 22, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING INSPECTION IT WAS NOTICED THAT 4 PLATE CUTTING FORCEPS WERE DULLED. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11711078 ↗
• MalfunctionDec 16, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED DURING THE TKA PROCEDURE, THAT THE FORCEPS WERE FOUND DULL. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, USING A BACKUP FROM SMITH & NEPHEW. 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 11021698 ↗
• MalfunctionDec 16, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED DURING THE TKA PROCEDURE, THAT THE FORCEPS WERE FOUND DULL. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, USING A BACKUP FROM SMITH & NEPHEW. 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 11021611 ↗
• MalfunctionSep 28, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE PLATE CUTTING FORCEPS ARE DULL. THERE WAS NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10591759 ↗
• MalfunctionSep 28, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE PLATE CUTTING FORCEPS ARE DULL. THERE WAS NO CASE INVOLVED.

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

  MAUDE report 10591708 ↗
• MalfunctionAug 14, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE SURGEON COMPLAINED THAT CUTTERS ARE DULL AND NEED TO BE REPLACED. EVOS MINI CASE. NO DELAY REPORTED AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10411123 ↗
• MalfunctionAug 14, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE SURGEON COMPLAINED THAT CUTTERS ARE DULL AND NEED TO BE REPLACED. EVOS MINI CASE. NO DELAY REPORTED AND PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10411102 ↗
• MalfunctionAug 14, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING SURGERY THE SURGEON COMPLAINED THAT CUTTERS ARE DULL AND NEED TO BE REPLACED. EVOS MINI CASE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY WITH THE SAME DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10411087 ↗
• MalfunctionAug 14, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE SURGEON COMPLAINED THAT CUTTERS ARE DULL AND NEED TO BE REPLACED. EVOS MINI CASE. PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10408322 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123598. One submission often covers many models, so check the product and lot details in each record.

• Z-0730-2019 · Jan 7, 2019 · Terminated
  SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
• Z-1008-2017 · Nov 16, 2016 · Terminated
  REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116