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No Brand 71935069Recalls & reported problems

Smith & Nephew, Inc. · CANNULATED DRILL PAC · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556533284), received between Jan 29, 2021 and Mar 9, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Device problems

  • Break1
  • Component Missing1
  • Positioning Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • Rupture1

Recent adverse event reports

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

  • InjuryMar 9, 2023Positioning Problem; Positioning Problem

    IT WAS REPORTED THAT, DURING A MENISCAL ROOT REPAIR SURGERY, SURGEON MADE FOUR ATTEMPTS TO DRILL THE TUNNEL USING A CANNULATED DRILL PAC; HOWEVER EACH TIME, THE SURGEON MISSED THE TARGET SPOT BY 5 MM. SURGERY RESUMED AFTER A SURGICAL DELAY GREATER THAN 30 MINUTES, BY USING A BACK-UP CANNULATED DRILL WHICH DRILLED EXACTLY IN THE SPOT. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: Rupture

    MAUDE report 16513085 ↗
  • MalfunctionMar 14, 2022Break; Break

    IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, A CANNULATED DRILL PAC BROKE AT THE BOTTOM, UNABLE TO LOAD ON CHUCK. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO DELAY NOR FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13759137 ↗
  • InjuryJan 29, 2021Component Missing; Component Missing

    IT WAS REPORTED THAT, DURING A MENISCAL ROOT REPAIR PROCEDURE, THE CANNULATED DRILL PAC WAS FOUND WITH ONLY 1 UNIT OF DRILL AND 1 UNIT OF SHEATH. AS IT WAS A DOUBLE TUNNEL MENISCUS ROOT, THE PROCEDURE WAS COMPLETED WITHOUT DELAY AS THE OT STAFF MANAGED TO FIND ANOTHER SHEATH (HOSPITAL UNIT). THERE WAS NO DELAY. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11250250 ↗

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Sources and updates

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