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DHS 280.950Recalls & reported problems

Synthes GmbH · DHS®/DCS® LAG SCREW 12.7MM THREAD/95MM · Class 2 · Implant

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982176332), received between Mar 21, 2018 and Nov 15, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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

  • Adverse Event Without Identified Device or Use Problem2
  • Device Operates Differently Than Expected1

Patient problems

  • No Code Available2
  • Necrosis1

Recent adverse event reports

The 3 most recent of 3 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) 135 DEG DHS PL-STD BARREL 2 HOLES/46. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

    Patient problems: Necrosis

    MAUDE report 15800830 ↗
  • InjuryOct 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT HARDWARE REMOVAL DUE TO PROXIMAL FEMUR FRACTURE LOSS OF REDUCTION WITH DYNAMIC HIP SCREW SYSTEM (DHS) + CANNULATED SCREW AND WAS REVISED TO TOTAL HIP. THE PROCEDURE OUTCOME AND PATIENT'S STATUS ARE UNKNOWN. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) DHS®/DCS® LAG SCREW 12.7MM THREAD/95MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

    Patient problems: No Code Available

    MAUDE report 10629380 ↗
  • InjuryMar 21, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

    IT WAS REPORTED THAT DURING A UNKNOWN PROCEDURE ON (B)(6) 2018, WHILE THE SURGEON WAS USING THE DHS®/DCS® WRENCH, FOR INSERTING A DHS®/DCS® COUPLING SCREW, UPON INSERTION INTO THE FEMORAL HEAD, THE DHS®/DCS® WRENCH WOULD NOT DISCONNECT AND SLIDE OFF FROM GUIDE SHAFT ASSEMBLY (DHS®/DCS® CENTERING SLEEVE AND DHS®/DCS® GUIDE SHAFT). DHS®/DCS® LAG SCREW 12.7 MM THREAD/95 MM (PART # 280.950, LOT # 5522496, QTY # 1) WAS ATTACHED TO THE GUIDE SHAFT AND COUPLING SCREW AND WAS NOT ABLE TO DETACH BECAUSE IT WAS STUCK INSIDE OF THE WRENCH. UPON TRYING TO DISCONNECT IT, THE HANDLE BROKE OFF THE DHS WRENCH. THE DHS®/DCS® COUPLING SCREW AND THE GUIDE SHAFT ASSEMBLY WERE REMOVED BY MOVING BACK AND FORTH. THERE WAS A SURGICAL DELAY OF 8-10 MINUTES. THE SURGERY WAS COMPLETED USING THE DYNAMIC HELICAL HIP SYSTEM (DHHS). THE PATIENT WAS UNHARMED. CONCOMITANT DEVICES REPORTED: DHS®/DCS® COUPLING SCREW (PART # 338.20, LOT # UNKNOWN, QTY #1) THIS IS REPORT 4 OF 4 FOR PC-(B)(4).

    Patient problems: No Code Available

    MAUDE report 7360152 ↗

Other APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT devices

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

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.