DHS 280.900Recalls & reported problems
Synthes GmbH · DHS®/DCS® LAG SCREW 12.7MM THREAD/90MM · Class 2 · Implant
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982176318), received between Oct 10, 2017 and Nov 15, 2022 — classified as 4 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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
- Adverse Event Without Identified Device or Use Problem3
- Device-Device Incompatibility3
- Material Deformation1
Patient problems
- No Code Available2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Bone Fracture(s)1
- Necrosis1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- Unspecified Infection1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT UNDERWENT DYNAMIC HIP SYSTEM (DHS). THERE WAS AVN / OSTEONECROSIS OF THE FEMORAL HEAD POSTOPERATIVE COMPLICATIONS REPORTED. THIS REPORT IS FOR ONE (1) DHS/DCS LAG SCREW 12.7MM THREAD/90MM. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).
Patient problems: Necrosis
MAUDE report 15798594 ↗InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A REMOVAL OF HARDWARE AND REVISION OF OPEN REDUCTION INTERNAL FIXATION(ORIF) LEFT FEMUR DUE TO FAILED FIXATION. LEFT HIP, FAILED DHS CONSTRUCT FOR SUBTROCH PROXIMAL FEMUR FRACTURE. THE ORIGINAL SURGERY WAS ON (B)(6) 2021. THIS REPORT IS FOR (1) DHS/DCS LAG SCREW 12.7MM THREAD/90MM. THIS IS REPORT 3 OF 7 FOR COMPLAINT (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12902646 ↗MalfunctionOct 12, 2021Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, A DYNAMIC HIP SCREW (DHS) PLATE COULD NOT BE ENGAGED OVER THE LAG SCREW. THE BUTT END OF THE SCREW SEEMS TO BE DEFECTIVE. A REPLACEMENT SCREW WAS USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF TEN MINUTES. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A DHS/DCS LAG SCREW, THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12616554 ↗MalfunctionMay 27, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT AN INTERTROCHANTERIC (IT) HIP FRACTURE REPAIR USING DYNAMIC HIP SCREW SYSTEM (DHS). DURING THE PROCEDURE, THE DYNAMIC HIP AND CONDYLAR SCREW SYSTEM (DHS/DCS) LAG SCREW WOULD NOT ALLOW THE PLATE BARREL TO SLIDE AS INTENDED. THE PLATE BARREL WAS NOT THE ISSUE, AS IT WAS TRIED ON OTHER SCREW SIZES AND IT SLID EFFORTLESSLY. THE REASON THE BARREL WOULD NOT SLIDE DOWN THE SCREW COULD NOT BE IDENTIFIED, BUT THE SCREW WAS THE PROBLEM DUE POSSIBLE DAMAGE. A 95MM LAG SCREW WAS USED INSTEAD OF THE INTENDED 90MM. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A TEN TO FIFTEEN (10-15) MINUTES SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: PLATES: DHS/DCS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) DHS/DCS LAG SCREW 12.7MM THREAD/90MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10091589 ↗InjuryNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
UPDATE: THIS REPORT IS FOR ONE (1) DHS®/DCS® LAG SCREW 12.7MM THREAD/90MM.
Patient problems: Bone Fracture(s); No Code Available; Unspecified Infection
MAUDE report 9312080 ↗InjuryFeb 15, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING HIP CASE ON (B)(6) 2019, THE SURGEON INSERTED 90MM DYNAMIC HIP AND CONDYLAR SCREW SYSTEM (DHS/DCS) LAG SCREW THEN PROCEEDED TO PUT A PLATE OVER THE LAG SCREW BUT THE PLATE WOULD NOT FIT OVER THE LAG SCREW. THE SURGEON EXTRACTED THE LAG SCREW OF THE PATIENT AND CHECKED AGAIN IF THE LAG SCREW WOULD FIT THROUGH THE PLATE BUT IT DID NOT. HE ENDED UP USING 85MM LAG SCREW AND EVERYTHING FIT TOGETHER PERFECTLY. THERE WAS A SURGICAL DELAY OF 20 MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ISSUE. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) DHS®/DCS® LAG SCREW 12.7MM THREAD/90MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Code Available
MAUDE report 8346101 ↗MalfunctionOct 10, 2017Material Deformation; Material Deformation
IT WAS REPORTED THAT A 90MM LAG SCREW HAD A BURR ON THE METAL BECAUSE OF WHICH THE BARREL OF THE DYNAMIC HIP SYSTEM (DHS) PLATE WAS NOT ABLE TO SLIDE OVER. THE EVENT HAPPENED DURING THE SURGERY. THERE WAS A SURGICAL DELAY OF ABOUT 10 MINUTES. THE SURGERY WAS SUCCESSFULLY COMPLETED BY USING THE SECOND SET AND THE PATIENT WAS FINE AFTER THE SURGERY. CONCOMITANT DEVICES REPORTED: DYNAMIC HIP SYSTEM (DHS) PLATE. THIS REPORT IS FOR ONE (1) DHS. DCS LAG SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6936872 ↗
Other APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT devices
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- 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
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.