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DHS 280.990Recalls & reported problems

Synthes GmbH · DHS®/DCS® COMPRESSION SCREW 36MM · Class 2 · Implant

Adverse event reports
3
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982176356), received between Apr 4, 2018 and Jan 12, 2026 — classified as 1 injury, 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break2
  • Adverse Event Without Identified Device or Use Problem1
  • Material Fragmentation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Code Available1
  • Nonunion/Delayed-union Bone Fracture1
  • Not Applicable1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 12, 2026Break

    IT WAS REPORTED THAT THE COMPRESSION SCREW HEAD WAS BROKEN DURING INSERTION. BROKEN HEAD WAS REMOVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24038983 ↗
  • InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REVISION PROCEDURE OF THE TWO (2) HOLES UNKNOWN DHS PLATE, THE UNKNOWN 7.3MM CANNULATED SCREW, THE DHS COMPRESSION SCREW AND THE TWO (2) UNKNOWN CORTEX SCREW FAILED FIXATION. INITIALLY, THE PATIENT WAS IMPLANTED WITH A DYNAMIC HIP AND CONDYLAR SCREW SYSTEM (DHS) IN (B)(6) 2019. THE PATIENT DID NOT HEAL SO THERE WAS A NONUNION OF THE FRACTURE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) DHS®/DCS® COMPRESSION SCREW 36MM-STERILE. THIS IS REPORT 3 OF 5 FOR (B)(4).

    Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

    MAUDE report 10818209 ↗
  • MalfunctionApr 4, 2018Break; Material Fragmentation; Break; Material Fragmentation

    IT WAS REPORTED THAT WHILE ATTEMPTING TO IMPLANT THE DHS/DCS COMPRESSION SCREW DURING A CASE ON (B)(6) 2018 THE LAST FEW TURNS BECAME VERY DIFFICULT. ON THE LAST TURN THE SET SCREW (HEAD OF THE DHS/DCS SCREW) SNAPPED OFF AND WAS DISCARDED. THE REMAINDER OF THE COMPRESSION SCREW REMAINS IMPLANTED. PROPER COMPRESSION WAS ACHIEVED, AND THE PRODUCT PERFORMED AS EXPECTED. NO SURGEON FOLLOW UP REQUIRED. THERE WAS NO SURGICAL DELAY, AND THE PATIENT'S OUTCOME WAS REPORTEDLY GOOD. THERE IS ONE DEVICE INVOLVED IN THIS COMPLAINT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: Not Applicable

    MAUDE report 7396855 ↗

Other APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT devices

All APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT devices →

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