MiniBunion™ MinBunion Capital Fragment Guide Kit - SterileRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815432029297), received between Dec 14, 2023 and Jan 11, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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.

• MalfunctionJan 11, 2024Defective Device; Device-Device Incompatibility; Defective Device; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THE 1.6MM K-WIRES THAT ARE SUPPOSED TO FIT IN THE MINIBUNION CAPITAL FRAGMENT GUIDE WOULD NOT FIT IN THE HOLES. THE STAFF TRIED TO USE SMALLER WIRES, BUT THOSE WERE NOT RIGID ENOUGH TO BE USED IN THE CASE. THEY CONTINUED THE CASE, AND THE PATIENT OUTCOME WAS NOT AFFECTED. THIS REPORT INVOLVES ONE MINIBUNION CAPITAL FRAG CTRL GUIDE STER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490877 ↗
• MalfunctionJan 3, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT SURGEON WAS PERFORMING A MINI-BUNION PROCEDURE ON (B)(6) 2023, AT APPROXIMATELY 8AM. SALES REP WAS COVERING THE CASE. WHILE ATTEMPTING TO UTILIZE THE CAPITAL FRAGMENT CONTROL GUIDE (AKA: VIKING SHIP) DR WAS UNABLE TO GET THE SUPPLIED 1.6MM K-WIRES INTO ANY OF THE HOLES. SMALLER K-WIRES WERE UTILIZED THAT FIT INTO THE HOLES. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT OUTCOME. THIS REPORT IS FOR ONE (1) MINIBUNION CAPITAL FRAG CTRL GUIDE STER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18434180 ↗
• MalfunctionDec 14, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE HOLES IN THE CAPITAL FRAGMENT CONTROL GUIDE WERE FOUND TO BE TOO SMALL FOR THE PINS PROVIDED. THIS SAME ISSUE WAS FOUND ON BOTH IPS IN QUESTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A SMALLER WIRE TO PASS THROUGH THE CAPITAL FRAGMENT GUIDE. THIS REPORT IS FOR A MINIBUNION CAPITAL FRAGMENT GUIDE KIT ¿ STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18326516 ↗
• MalfunctionDec 14, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE HOLES IN THE CAPITAL FRAGMENT CONTROL GUIDE WERE FOUND TO BE TOO SMALL FOR THE PINS PROVIDED. THIS SAME ISSUE WAS FOUND ON BOTH IPS IN QUESTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A SMALLER WIRE TO PASS THROUGH THE CAPITAL FRAGMENT GUIDE. THIS REPORT IS FOR A MINIBUNION CAPITAL FRAGMENT GUIDE KIT ¿ STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18326509 ↗