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PRESSFT NDB21HRecalls & reported problems

Conmed Corporation · PRESSFT DRILL BIT, HIP, 2.1 MM · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854027936), received between Sep 4, 2018 and Sep 4, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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

Device problems

  • Fracture1

Patient problems

  • Device Embedded In Tissue or Plaque1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjurySep 4, 2018Fracture; Fracture

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE NDB21H, PRESSFT DRILL BIT, 2.1 MM, HIP, DEVICE DRILL TIP BROKE OFF WHILE DRILLING A HOLE FOR THE ANCHOR AND WAS NOT ABLE TO BE REMOVED FROM PATIENT. THIS EVENT TOOK PLACE DURING A HIP ARTHROSCOPY ON (B)(6) 2018 CAUSING A 10-MINUTE DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN ALTERNATE DEVICE. THE TIP WAS NOT REMOVED FROM THAT PATIENT DUE TO BEING TOO DIFFICULT TO REMOVE BEING THAT IT WAS EMBEDDED IN THE BONE. IT WAS REPORTED THAT THERE WAS NO INJURY TO THE PATIENT OR THE USER. NO EXTENDED HOSPITALIZATION OR SURGICAL INTERVENTION WAS REQUIRED. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO THE TIP BEING LEFT IN THE PATIENT.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 7843937 ↗

Other BIT, SURGICAL devices

All BIT, SURGICAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.