DHS 280.850Recalls & reported problems
Synthes GmbH · DHS®/DCS® LAG SCREW 12.7MM THREAD/85MM · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982176295), received between Jan 11, 2017 and Apr 9, 2021 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Fitting Problem” (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.
Most reported problems
Device problems
- Fitting Problem2
- Material Deformation1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 9, 2021Material Deformation; Material Deformation
IT WAS REPORTED THAT ON UNKNOWN DATE, AN UNKNOWN SURGICAL PROCEDURE WAS PERFORMED. THE CONNECTING SCREW FOR DYNAMIC HIP SYSTEM (DHS) BENT WHILE INSERTING SIDE PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF THIRTY (30) MINUTES. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES TWO(2) DEVICES. THIS REPORT IS FOR ONE DHS®/DCS® LAG SCREW 12.7MM THREAD/85MM THIS REPORT IS 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11642214 ↗MalfunctionDec 10, 2018Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, A DYNAMIC HIP AND CONDYLAR SCREW SYSTEM (DHS/DCS) WRENCH ROTATED AROUND THE DHS/DCS LAG SCREW DAMAGING THE INTERNAL HEX ON BOTH THE WRENCH AND LAG SCREW. BOTH ITEMS ARE NO LONGER USABLE. SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF TEN (10) MINUTES. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR A DHS®/DCS® LAG SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8148423 ↗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 COUPLING 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 DEVICES REPORTED: 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 NU
Patient problems: No Code Available
MAUDE report 6386174 ↗MalfunctionJan 11, 2017Fitting Problem; Fitting Problem
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A DYNAMIC HIP SCREW (DHS) PLATE DOES NOT FIT WITH A DYNAMIC HIP SCREW AND CONDYLAR SCREW (DHS / DCS) DURING SURGERY ON (B)(6) 2016. THERE WAS NO PROLONGATION OF SURGERY AND ALSO NO PATIENT HARM. THERE WERE SUBSTITUTE PARTS USED TO FINALIZE THE SURGERY SUCCESSFULLY. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6241043 ↗
Other APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT devices
- PRECICE® Plating System LP4.5-DLF31Nuvasive Specialized Orthopedics, Inc. · Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component3 recalls0 reports
- R3 71364451Smith & Nephew, Inc. · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT145 reports
- 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 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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