NA 213072Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705002603), received between Nov 25, 2019 and Aug 3, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

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

• MalfunctionAug 3, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE INNER CHANNEL OF THE DRILL GUIDE MINI DEVICE HAD A METAL PROTRUSION THAT WAS NOT ALLOWING TO DRILL THROUGH THE DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12269182 ↗
• MalfunctionFeb 26, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY AFFILIATE VIA E-MAIL THAT WHEN THE MINI DRGDE *EA WAS PREPARING FOR ITS FIRST STERILIZATION, IT WAS NOTICED THAT IT WAS PARTIALLY BLOCKED ON THE CANNULATED SECTION OF THE GUIDE. THE DEVICE WAS NOT USED ON A PATIENT. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9759305 ↗
• MalfunctionNov 25, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A THUMB REPAIR PROCEDURE, IT WAS OBSERVED THAT THE CUSTOMER'S DRILL GUIDE MINI WAS BENT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITHOUT THE DEVICE WITH NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9369187 ↗