INSTRUMENT I-K4112OT00Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327418965), received between Mar 19, 2019 and Mar 17, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Mechanical 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2020Positioning Failure; Detachment of Device or Device Component; Positioning Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PRIMARY KNEE PROCEDURE, WHEN THE BLADE CUTTER OF THE DEVICE TOUCHES THE PATELLA, THE JOINT TO THE PATELLA JAWS GETS LOOSE. A SAW HAD TO BE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO DELAY. THIS IS THE SECOND TIME THIS HAS HAPPENED WITH THIS DEVICE AND SURGEON, ANOTHER DEVICE OF THE SAME CATALOG NUMBER. NO OTHER INFORMATION IS AVAILABLE. UPDATE APRIL 23, 2020: THE SURGEON PROVIDED ADDITIONAL INFORMATION VIA THE SALES REPRESENTATIVE. HE BELIEVES THE MATING DEVICE, PATELLA MILLING CLAMP ASSEMBLY, WAS THE LIKELY CAUSE OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9842088 ↗
• MalfunctionOct 28, 2019Mechanical Problem; Mechanical Problem

  LOCKING MECHANISM WAS TOO WEAK SO THE DEVICE SPUN OUT AND CUT OPEN SURGEON'S HAND. CASE WAS COMPLETED SUCCESSFULLY WITH A 5 - 10 MINUTE DELAY. NO ADDITIONAL INFORMATION IS AVAILABLE. UPDATE (B)(6) 2020: THE SURGEON PROVIDED ADDITIONAL INFORMATION VIA THE SALES REPRESENTATIVE. HE BELIEVES THE MATING DEVICE, PATELLA MILLING CLAMP ASSEMBLY, WAS THE LIKELY CAUSE OF THIS EVENT AND THE SHARP OBJECT THAT CAUSED HIS WOUND. HIS WOUND DID NOT REQUIRE MEDICAL ATTENTION. AFTER CLEANING HIS HAND AND CHANGING HIS GLOVE, HE COMPLETED THAT SURGERY SUCCESSFULLY AND PERFORMED OTHER SURGERIES THROUGHOUT THE DAY. THE SURGEON IS NOT RETURNING THE PATELLA MILLING CLAMP FOR INVESTIGATION.

  Patient problems: Injury

  MAUDE report 9246435 ↗
• MalfunctionMar 19, 2019Mechanical Problem; Mechanical Problem

  CUSTOM PATELLA REAMER WAS PRESENTED TO SURGEON FOR SAWBONE DEMO AND THE SHAFT GETS STUCK WHEN FULLY ENGAGED.

  Patient problems: No Patient Involvement

  MAUDE report 8433737 ↗