SPECIALIST 96-6361Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295248118), received between May 2, 2018 and Dec 2, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE PUNCH IS WORN AND WILL NOT PROPERLY CONNECT TO OTHER INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15907469 ↗
• MalfunctionFeb 2, 2022Break; Break

  MOVING BAR BROKE DURING PROCEDURE. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13428235 ↗
• MalfunctionSep 27, 2018Break; Break

  IT WAS REPORTED THAT THE PF*2 MOD TB CE PUN GD SZ 4-6 BROKE AND WILL NOT ATTACH TO A TIBIA TRIAL FOR TIBIA PREPARATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7915648 ↗
• MalfunctionMay 2, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT TIBIA PUNCH AND DRILL GUIDE HANDLE WASN¿T RELEASING OFF OF TIBIA BASE PLATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7479507 ↗