ASNIS 325036Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327077957), received between Sep 11, 2025 and Sep 11, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjurySep 11, 2025Material Fragmentation; Material Fragmentation

  AS REPORTED: "A LOANER INSTRUMENT TRAY WAS BROUGHT BY THE STRYKER REPRESENTATIVE AND STERILIZED FOR USE BY OUR CSR TEAM. PATIENT TAKEN TO OPERATING ROOM ON (B)(6) 2025 AND WAS UNDERGOING A ORIF (OPEN REDUCTION INTERNAL FIXATION) OF THE RIGHT PATELLAR. THE ORTHOPEDIC SURGEON INSERTED A 4.0 36 CANNULATED SCREW INTO THE RIGHT PATELLA. THE STRYKER VENDOR WAS PRESENT AND THE ENTIRE PROCEDURE WAS PERFORMED UNDER FLUOROSCOPY. WHEN INSERTING, THE SURGEON NOTED A PULLING SENSATION AND NOTED THAT THE SCREW APPEARED TO BE MOVING. UPON VISUALIZATION 2 SMALL THREADS OF THE SCREW WERE NOTED IN THE PATELLA. ONE FRAGMENT WAS IMMEDIATELY REMOVED ALONG WITH THE SCREW AND THE SECOND COULD NOT BE RETRIEVED, PER THE SURGEON, SINCE IT WAS IMBEDDED IN THE BONE. THE REMAINDER OF THE PROCEDURE (REPLACEMENT SCREW INSERTED) PROCEEDED WITHOUT INCIDENT. THE RIGHT KNEE WAS BANDAGED AND PLACED IN A KNEE IMMOBILIZER. THE PATIENT WAS RECOVERED IN PACU AND TRANSFERRED TO A MED/SURG UNIT IN STABLE CONDITION. THE PATIENT WAS INFORMED OF THE RETAINED FOREIGN BODY. SHE WAS MEDICATED FOR PAIN PRN".

  Patient problems: Foreign Body In Patient

  MAUDE report 23030660 ↗