N/A DK-265CRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810633022092), received between Aug 10, 2021 and Aug 10, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 WHILE USING THE CONTINUOUS COMPRESSION IMPLANTS (CCI), THERE WAS DIFFICULTY DRILLING INTO THE BONE. INSTEAD OF DRILLING A HOLE, THE DRILL PUSHED THE BONE AND DISPLACED THE FRACTURE. AFTER THE STAPLE WAS INSERTED, THE CCI DID NOT FIT PROPERLY AND HAD TO BE REMOVED BECAUSE THE HOLE WAS NOT PERFECT. THERE WAS A 10 MINUTE DELAY. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES USING ANOTHER STERILE IMPLANT. CONCOMITANT DEVICE: UNK - DRILL BITS: TRAUMA(PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR 1 SPEED 2.65MM INSTRUMENT KIT COMPREHENSIVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12300642 ↗