Knee Instruments 1.100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630971215047), received between Apr 14, 2022 and Apr 14, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2022Fracture; Fracture

  DURING A KNEE SURGERY, THE SURGEON POSITIONED THE INTRAMEDULLARY ROD IN THE PATIENT'S CANAL, HIT IT WITH A HAMMER TO INSERT THE INSTRUMENT IN THE TIBIAL BONE AND TO BLOCK THE ROTATION (THE 9MM DRILL WAS USED TO PREPARE THE CANAL). THEN THE SURGEON STARTED THE LATERAL TIBIAL CUT, DISMANTLED THE STEM GUIDE SYSTEM AND REMOVED IT IN ORDER TO BE ABLE TO FINISH THE CUT. WHILE HE WAS DISASSEMBLING THE INSTRUMENTS DISCOVERED THAT THE INTRAMEDULLARY ROD WAS BROKEN AND A PIECE OF 10/15 CM REMAINED IN THE PATIENT'S CANAL. THE SURGEON DECIDED TO NOT REMOVE THE FRAGMENT AS THERE WAS NO RISK OF MIGRATION AND TO AVOID VASCULAR NERVE INJURY, INFECTION, LOSS OF MOBILITY AND MUSCLE INJURY. THE SURGERY WAS FINISHED SUCCESSFULLY WITHOUT ANY OTHER COMPLICATION. THE INTRAMEDULLARY ROD WAS IN THE CLINIC AS A CONSIGNMENT SINCE ABOUT 6/7 MONTHS. IT WAS USED APPROXIMATELY FOR 30/40 SURGERIES WITHOUT ISSUES.

  Patient problems: Foreign Body In Patient

  MAUDE report 14109995 ↗