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NA 03.010.039Recalls & reported problems

Synthes GmbH · 10.0MM CANNULATED AWL · Class 1

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982067128), received between Jul 8, 2022 and Jul 8, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Cut” (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

  • Failure to Cut1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJul 8, 2022Failure to Cut; Failure to Cut

    IT WAS REPORTED THAT ON (B)(6) 2022, THE HUMERAL NAIL 10.0MM CANNULATED AWL IS DULL AND WILL NOT CUT BATHY INTO BONE. IT IS ORIGINAL TO SET 10 PLUS YEARS. NO DELAY TO SURGERY AS SURGEON USED OPENING DRILL BIT ONCE REALIZING AWL TO DULL. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. PATIENT CONSEQUENCE IS UNKNOWN. THIS REPORT IS FOR ONE (1) 10.0MM CANNULATED AWL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14961176 ↗

Other AWL devices

All AWL devices →

Sources and updates

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