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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

All APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT devices →

Sources and updates

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