DHS 280.305Recalls & reported problems
Synthes GmbH · DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/105MM · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982175236), received between May 29, 2019 and May 29, 2019 — classified as 1 injury.
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 Problem1
Patient problems
- No Code Available1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HARDWARE REMOVAL OF DYNAMIC HIP SCREW (DHS) IMPLANT CONSTRUCTS FOR A FEMORAL NECK FRACTURE ON (B)(6) 2019 AS THAT ENDED UP NOT HEALING. SURGEON TOOK OUT THE HARDWARE AND REVISED PATIENT TO TOTAL HIP ARTHROPLASTY. DHS WAS REMOVED WITH NO ISSUES. ORIGINAL IMPLANT DATE WAS (B)(6) 2018. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) DHS/DCS ONE STEP LAG SCREW. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture
MAUDE report 8649504 ↗
Other DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT devices
- 13 X 90mm LAG FASTENER 324-13090Osteocentric Technologies, Inc. · Device, Fixation, Proximal Femoral, Implant1 report
- CONQUEST FN 71179203Smith & Nephew, Inc. · DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT1 report
- DHS 280.295Synthes GmbH · DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT1 report
- CONQUEST FN 75808095Smith & Nephew, Inc. · DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT1 report
- DHS 281.031SSynthes GmbH · DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT1 report
- CONQUEST FN 71179213Smith & Nephew, Inc. · DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT1 report
- DHS 280.285SSynthes GmbH · DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT1 report
- DHS 281.504Synthes GmbH · DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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