ORTHO SOLUTIONS ULTOS PLATING SYSTEM OS200125Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05055662931105), received between Jan 17, 2020 and Mar 2, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K141784); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2021Fracture; Fracture

  REPORTEDLY, DURING A QUADS REPAIR SURGICAL PROCEDURE, THE DRILL BIT FRACTURED DURING USE TO DRILL SOFT BONE. THE DRILL TIP WAS RETAINED WITHIN THE PATIENT, AND WAS UNABLE TO BE RETRIEVED. NO ADDITIONAL COMPLICATIONS WERE REPORTED FOR THE PATIENT AT THE TIME OF REPORT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11397749 ↗
• MalfunctionDec 15, 2020Fracture; Fracture

  DRILL BROKEN DURING A TOTAL HIP REPLACEMENT PROCEDURE; THE DRILL TIP COULDN'T BE FOUND AND SUBSEQUENTLY, AN X-RAY WAS CALLED INTO THEATRE TO IDENTIFY THE DRILL TIP. THE FRAGMENT WAS FOUND NEAR THE STEM, SO IT WOULD CAUSE MORE DAMAGE TRYING TO RETRIEVE IT. NO OTHER CLINICAL INFORMATION WAS AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11012540 ↗
• MalfunctionMar 24, 2020Fracture; Fracture

  THE DRILL FRACTURED DURING SURGERY. A SECOND DRILL OF THE SAME PRODUCT CODE WAS USED TO COMPLETE THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH MINOR DELAY CAUSED. MOST OF THE DRILL TIP (THE FLUTED SECTION) REMAINS INSIDE THE PATIENT. THE SURGEON DECIDED NOT TO ATTEMPT TO REMOVE THE BROKEN DRILL SECTION. NO ADDITIONAL PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9871745 ↗
• MalfunctionJan 17, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A LEFT TIBIAL TUBERCLE TRANSFER AND PATELLAR STABILISATION PROCEDURE THAT AS THE SURGEON WAS DRILLING THE TIBIA WITH THE DRILL BIT, THE DRILL BIT SNAPPED AS IT CONTACTED THE DISTAL CORTEX OF THE TIBIA. X-RAYS WERE DONE AND THE END OF THE DRILL WAS LEFT IN THE TIBIA AFTER FURTHER ASSESSMENT BY THE CONSULTANT, AS IT WAS IRRETRIEVABLE. THE PATIENT WAS NOTED TO HAVE HARD BONE.

  Patient problems: No Information

  MAUDE report 9602143 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141784. One submission often covers many models, so check the product and lot details in each record.

• Z-0230-2026 · Sep 17, 2025 · Open, Classified
  Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS200020L, OS200025L, OS200120L, OS200125, OS200125L, OS200135, OS200324, OS200325, OS
• Z-0026-2016 · Jul 14, 2015 · Terminated
  Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Steril