DHS 280.280Recalls & reported problems
Synthes GmbH · DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/80MM · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982175113), received between Oct 10, 2018 and Sep 21, 2021 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Bone Fracture(s)1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, THE PATIENT UNDERWENT A PROCEDURE DUE TO FRACTURE THAT OCCURRED BELOW TWO HOLE DYNAMIC HIP SYSTEM (DHS) PLATE. THE DHS WAS REMOVED EASILY, AND A TROCHANTERIC FEMORAL NAILING ADVANCED (TFNA) WAS USED TO REPAIR THE FRACTURE. THIS REPORT IS FOR ONE (1) DHS/DCS ONE-STEP LAG SCREW 12.7MM THREAD/80MM. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).
Patient problems: Bone Fracture(s)
MAUDE report 12509403 ↗InjuryOct 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DHS PLATE, LAG SCREW AND CANNULATED SCREW WERE INTACT, THE TWO (2) CORTEX SCREWS WERE BROKEN AT THE HEAD.
Patient problems: No Code Available
MAUDE report 7953909 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.