DHS 280.000Recalls & reported problems
Synthes GmbH · DHS®/DCS® LAG SCREW 12.7MM THREAD/100MM · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982174871), received between Jun 5, 2017 and Oct 8, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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.
Most reported problems
Device problems
- Device-Device Incompatibility1
- Fitting Problem1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 8, 2019Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A FEMUR FRACTURE ON (B)(6) 2019, THE DYNAMIC HIP SCREW (DHS) SCREW HAD A DEFECT; NOT FITTING THE PLATE. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES: PLATE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A DHS®/DCS® LAG SCREW 12.7MM THREAD. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9166071 ↗MalfunctionJun 5, 2017Fitting Problem; Fitting Problem
IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A HIP FRACTURE SURGERY WITH SYNTHES DYNAMIC HIP SYSTEM (DHS) ON (B)(6) 2017. HE EXPERIENCED DIFFICULTY PLACING THE DHS SIDE PLATE OVER THE JUST IMPLANTED SYNTHES LAG SCREW. AFTER STRUGGLING FOR SOME TIME, HE REMOVED THE LAG SCREW AND EXTRA-OPERATIVELY DISCOVERED THE LAG SCREW DID NOT FIT THROUGH THE BARREL OF THE SIDE PLATE. OTHER LAG SCREWS FROM THE SET WERE TESTED AND FIT FINE. THE EXPLANTED LAG SCREW WAS TRIALED THROUGH A DIFFERENT SIDE PLATE AND DID NOT FIT. THERE WERE NO FRAGMENTS GENERATED WHILE THE LAG SCREW WAS BEING EXPLANTED. NO UNANTICIPATED X-RAYS WERE TAKEN. THE SURGEON THEN IMPLANTED A LAG SCREW FROM A SECOND SET, SLID THE SIDE PLATE OVER THE LAG SCREW AND THE PROCEDURE WAS COMPLETED WITHOUT ANY INCIDENT. PATIENT'S OUTCOME IS UNKNOWN. THERE WAS A FORTY (40) MINUTE DELAY IN SURGERY. CONCOMITANT DEVICE REPORTED: SIDE PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1) THIS REPORT IS FOR ONE (1) DHS®/DCS® LAG SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6610816 ↗
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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