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DHS 338.005Recalls & reported problems

Synthes GmbH · 130 DEG DHS® ANGLE GUIDE · 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 10886982193032), received between Sep 26, 2023 and Sep 26, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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-Device Incompatibility1

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.

  • MalfunctionSep 26, 2023Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON (B)(6) 2023, THE DHS 130 DEGREE GUIDE AND T HANDLE WERE USED DURING A PROCEDURE. THE GUIDE KEPT DISENGAGING. WHILE INSERTING THE CSS+ LARGE SCREW, THE HANDLE QUIT RATCHETING AND BOTH SCREWDRIVER HEADS WERE STRIPPED. THE SCREW WAS INSERTED AND THE HEAD SNAPPED OFF DUE TO TORQUE. THERE WERE NO REPORTED PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 130 DEG DHS® ANGLE GUIDE. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17818762 ↗

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