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
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
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- DFS HA BONE SCREWS HAA60-15040Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 recalls0 reports
- DFS HA BONE SCREWS HAA60-15050Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 recalls0 reports
- DFS HA BONE SCREWS HAB60-12040Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 recalls0 reports
- DFS HA BONE SCREWS HAA60-13040Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 recalls0 reports
- DFS HA BONE SCREWS HAA60-18030Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 recalls0 reports
- DFS HA BONE SCREWS HAA60-15030Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.