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DHS 281.102Recalls & reported problems

Synthes GmbH · 135 DEG DHS® PLATE-STANDARD BARREL 2 HOLES/46MM · 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 10886982176608), received between Mar 7, 2017 and Jan 5, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Fitting Problem” (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.

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

  • Adverse Event Without Identified Device or Use Problem1
  • Fitting Problem1

Patient problems

  • Malunion of Bone1
  • No Code Available1
  • Nonunion/Delayed-union Bone Fracture1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THE PATIENT UNDERWENT HARDWARE REMOVE OF DHS ON (B)(6) 2025.

    Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture

    MAUDE report 23961441 ↗
  • InjuryMar 7, 2017Fitting Problem; Fitting Problem

    IT WAS REPORTED THAT THE PATIENT UNDER WENT A PROCEDURE ON (B)(6) 2017. DURING THE PROCEDURE THE DYNAMIC HIP SCREW (DHS) 2-HOLE PLATE WOULD NOT SLIDE OVER THE LAG SCREW. THE SURGEON TRIED TO USE A DHS IMPACTOR TO ADVANCE THE LAG SCREW BUT WAS NOT SUCCESSFUL AND PUSHED THE LAG SCREW INTO THE PATIENT'S ACETABULUM. THE SURGEON THEN USED A DHS COUPLING SCREW TO ENGAGE THE LAG SCREW. THE SURGEON USED PLIERS AND A MALLET TO TAP ON THE COULPING SCREW AND DRAG THE LAG SCREW HALFWAY OUT OF THE BONE. A DHS WRENCH WAS USED TO BACK TURN AND FINALLY REMOVE THE LAG SCREW. AN ADDITIONAL X-RAY WAS TAKEN DURING THE PROCEDURE FOR REMOVAL OF THE LAG SCREW. THESE EVENTS DID RESULT IN A 15 MINUTE SURGICAL DELAY. THE PROCEDURE WAS RESUMED USING AN TFN-ADVANCED PROXIMAL FEMORAL NAILING SYSTEM (TFNA). THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PROCEDURE WAS TOLERATED BY THE PATIENT. THIS COMPLAINT INVOLVES 2 DEVICES. CONCOMITANT MEDICAL PRODUCTS DHS REAMING HEAD- STANDARD- UNKNOWN PART AND LOT NUMBERS, QUANTITY X 1; DHS TRIPLE REAMER-COMPLETE- UNKNOWN PART AND LOT NUMBERS, QUANTITY X1; DHS/DCS WRENCH- PART 338.06, UNKNOWN LOT NUMBER, QUANTITY X 1; DHS/DCS CENTERING SLEEVE-LONG -UNKNOWN PART AND LOT NUM

    Patient problems: No Code Available

    MAUDE report 6386177 ↗

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.