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NA 395.45Recalls & reported problems

Synthes GmbH · HOLDING SLEEVE 45MM FOR MEDIUM DISTRACTOR · Class 1

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 10886982200327), received between Jan 17, 2022 and Jan 17, 2022 — classified as 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

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.

  • MalfunctionJan 17, 2022Break; Break

    IT WAS REPORTED THAT, THE FOLLOWING DEVICES WERE RECEIVED AS BLIND UNIT. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE 45 FOR MEDIUM DISTRACTOR. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13266405 ↗

Other APPARATUS, TRACTION, NON-POWERED devices

All APPARATUS, TRACTION, NON-POWERED devices →

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