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NA SD352.100Recalls & reported problems

Synthes GmbH · 10.0MM MEDULLARY REAMER HEAD FRONT CUTTING · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982005595), received between May 27, 2021 and May 27, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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

Device problems

  • Break2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 27, 2021Break; Break

    IT WAS REPORTED THAT, THE 10MM MEDULLARY REAMER HEAD FRONT CUTTING BROKE. PROCEDURE WAS DELAYED BY TEN (10) MINUTES AND NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 10.0MM MEDULLARY REAMER HEAD FRONT CUTTING. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11893377 ↗
  • MalfunctionMay 27, 2021Break; Break

    IT WAS REPORTED THAT, THE 10MM MEDULLARY REAMER HEAD FRONT CUTTING BROKE. PROCEDURE WAS DELAYED BY TEN (10) MINUTES AND NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 10.0MM MEDULLARY REAMER HEAD FRONT CUTTING. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11893372 ↗

Other REAMER devices

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Sources and updates

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