LARGE CANNULATED SCREWS 121638Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010063939), received between Jun 25, 2021 and Oct 25, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2022Migration; Migration

  IT WAS REPORTED THAT, FOLLOWING AN INTERNAL FIXATION SURGERY PERFORMED ON AN UNSPECIFIED DATE TO TREAT A FEMORAL FRACTURE WITH LARGE CANNULATED SCREWS, THE PATIENT SUSTAINED A SCREW PROMINENCE AND PAIN THAT REQUIRED AN ADDITIONAL SURGERY TO REMOVE THIS HARDWARE. A SPECIFIC DATE FOR THIS PROCEDURE WAS NOT PROVIDED, AND ADDITIONAL DETAILS REGARDING THE CLINICAL COURSE OF THE PATIENT REMAIN ALSO UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 15665571 ↗
• InjuryJun 25, 2021Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A INTRAMEDULLARY HIP SCREW (IMHS) SCREW HAD BEEN IMPLANTED ON (B)(6) 2014, THE PLAINTIFF SUFFERED A FALL ON (B)(6) 2014, AND WAS RE-HOSPITALISED DUE TO A SUBTROCHANTERIC FEMORAL FRACTURE AT A STATUS, AFTER SCREW FIXATION WITH A SLIPPED EPIPHYSIOLYSIS. A REVISION SURGERY WAS PERFORMED AND THE INTRAMEDULLARY SCREW WAS EXPLANTED. A NEW CANCELLOUS HIP SCREW FIXATION WITH A GAMMA NAIL WAS IMPLANTED. ON 13-FEB-2015, AFTER INVESTIGATION, IT WAS DETERMINED THAT THERE WAS A DEFECT IN THE PRIMARY SCREW IMPLANTED; SMITH & NEPHEW 6.5 MM X 75 MM LONG SCREW. THIS CAUSED ADDITIONAL INJURIES TO THE PATIENT. PER THE INFORMATION, PROVIDED THE REVISION SURGERY WAS THE CONSEQUENCE OF THE QUALITY OF THE PRIMARY IMPLANTED SCREW, WHICH WAS BROKEN. UPON MEDICAL EXAMINATION ON 5-OCT-2021, A RESIDUAL VARUS POSITION WAS DETERMINED FROM ASSESSING X-RAY IMAGES.

  Patient problems: Bone Fracture(s); Deformity/ Disfigurement; Failure of Implant; Hip Fracture

  MAUDE report 12071512 ↗