TC-100 71170183Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010181572), received between Jun 23, 2020 and May 26, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (6 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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE UNIVERSAL CHUCK BROKE OUTSIDE THE PATIENT. 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 11886979 ↗
• MalfunctionOct 20, 2020Break; Break

  IT WAS REPORTED THAT THE UNIVERSAL CHUCK SEEMS TO BE BROKEN. IT IS UNKNOWN WHERE THE EVENT OCCURS. 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; No Patient Involvement

  MAUDE report 10708406 ↗
• MalfunctionOct 14, 2020Connection Problem; Sharp Edges; Connection Problem; Sharp Edges

  IT WAS REPORTED THAT THE EDGES OF THE T HANDLE ARE BEGINNING TO BE SHARP FROM REPEATED MALLETING, THE PINCHERS NEAR THE FRONT ARE BENDING OVER AND ARE NOT GRABBING THE GUIDE ROD WITHOUT KNICKING IT. NO CASE INVOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10681367 ↗
• MalfunctionOct 14, 2020Connection Problem; Sharp Edges; Connection Problem; Sharp Edges

  IT WAS REPORTED THAT THE EDGES OF THE T HANDLE ARE BEGINNING TO BE SHARP FROM REPEATED MALLETING, THE PINCHERS NEAR THE FRONT ARE BENDING OVER AND ARE NOT GRABBING THE GUIDE ROD WITHOUT KNICKING IT. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10681350 ↗
• MalfunctionSep 24, 2020Connection Problem; Incomplete or Inadequate Connection; Connection Problem; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING SURGERY, DEVICE WOULD NOT GRIP PINS. A BACKUP DEVICE WAS USED TO COMPLETE THE PROCEDURE AND NO DELAY OR INJURY WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10583710 ↗
• MalfunctionSep 11, 2020Break; Break

  IT WAS REPORTED THAT THE UNIVERSAL CHUCK BROKE IN SURGERY. PROCEDURE WAS COMPLETED USING A SN BACKUP DEVICE. NO SURGICAL DELAY WAS REPORTED. IT WAS NOT REPORTED IF THE PATIENT SUFFERED FROM ANY HARM OR INJURY BECAUSE OF THE REPORTED FAILURE. 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 10524513 ↗
• MalfunctionAug 26, 2020Break; Break

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION THE DEVICE WAS NOTICED BROKEN AT THE HANDLE ASPECT AND THE CLAWS WON¿T GRIP DOWN ON THE PINS. NO DELAY OR HARM TO THE PATIENT REPORTED. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10457778 ↗
• MalfunctionAug 21, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING INSPECTION THE HANDLE WAS SEEN TO BE LOOSE ON THE SHAFT AT THE WELD. NO CASE RELATED THEREFORE NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10437597 ↗
• MalfunctionJul 27, 2020Break; Break

  IT WAS REPORTED THAT DURING OFFICE SET USED FOR BONE LAB EXPERIENCED THREE DEVICES BREAK. NOT USED IN ANY RECENT CASES AND NO ISSUES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10324902 ↗
• MalfunctionJun 23, 2020Break; Break

  IT WAS REPORTED THAT THE WELD FRACTURED ON THE T-HANDLE, PROBABLY UPON EXTRACTION OF GUIDE ROD DURING THE PROCEDURE. IT IS UNKNOWN IF IT HAPPENED INSIDE OR OUTSIDE THE PATIENT. IT IS UNKNOWN IF THERE WAS A DELAY OR HOW THE PROCEDURE WAS FINISHED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10183356 ↗

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