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SENTINEL S8590Recalls & reported problems

Conmed Corporation · SENTINEL CANNULATED DRILL BIT, 9 X 229 MM (9") · 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 10845854036853), received between Sep 9, 2019 and Sep 9, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Device Misassembled During Manufacturing /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

Device problems

  • Device Misassembled During Manufacturing /Shipping1

Patient problems

  • Injury1

Recent adverse event reports

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

  • InjurySep 9, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

    THE CUSTOMER REPORTED THAT S8590 DEVICE WAS BEING USED DURING A KNEE SURGERY CASE ON (B)(6) 2019. THE REPORTER STATES THAT "PATIENT INJURY OCCURRED BECAUSE THE INDICATOR LINE WAS PRINTED ON THE OPPOSITE SIDE AND THE CONDYLE WAS HIT WITH THE DRILL BIT." THERE WAS NO REPORTED DELAY IN THE PROCEDURE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY PER THE REPORTER. FURTHER ASSESSMENT INFORMATION WAS REQUESTED FROM THE FACILITY; HOWEVER, THE REPORTER HAS NOT RESPONDED TO ANY REQUEST THAT HAVE BEEN MADE. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO FACILITY REPORTING INJURY TO PATIENT.

    Patient problems: Injury

    MAUDE report 8975538 ↗

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.