NA 702601Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540112767), received between Oct 16, 2023 and Oct 16, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Residue After Decontamination” (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.

• InjuryOct 16, 2023Residue After Decontamination; Residue After Decontamination

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY ON OR ABOUT (B)(6) 2023, THE PATIENT HAD LAPAROSCOPIC SURGERY TO REPAIR A PELVIC FRACTURE USING A STRYKER DRILL AND STRYKER 6.5 CANULA. ALLEGEDLY DURING THE SURGERY, WHILE USING A STRYKER DRILL AND PUTTING HARDWARE AND SCREWS, THE SURGEON NOTICED THAT BLACK SLUDGE WAS COMING OUT OF THE STRYKER DRILL. IT IS ALLEGED ON (B)(6) 2023, THE PATIENT HAD DRAINAGE AND PUSS FROM THE INCISION SITE AND WAS TOLD SHE HAD AN INFECTION. ON (B)(6) 2023, THE PATIENT UNDERWENT A CT SCAN THAT REVEALED AN INFECTION AND A FOREIGN MATERIAL IN HER PELVIC REGION. ON (B)(6) 2023, THE PATIENT UNDERWENT A SECOND SURGERY TO REMOVE A LOOSE SCREW THAT HAD BEEN LEFT IN HER PELVIS. (COVERED BY ANOTHER PI)

  Patient problems: Unspecified Infection

  MAUDE report 17941774 ↗