LARGE CANNULATED SCREWS 71177138Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010601551), received between Apr 6, 2020 and Mar 9, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Failure to Calibrate” (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.

• InjuryMar 9, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT DURING SURGERY FOR NECK OF FEMUR USING SMITH AND NEPHEW CHS SYSTEM, THE SURGICAL TEAM DECIDED TO USE THE ANTI-ROTATION SCREW TREATMENT WITH SMITH AND NEPHEW 7.0MM CANNULATED SCREW SYSTEM. FOLLOWING CORRECT POSITIONING OF THE 3.2MM X 300MM THREADED GUIDE PIN, A MEASUREMENT WAS TAKEN USING THE 6.5/8.0MM DIRECT MEASURING GAUGE. REGISTRAR READ 105MM FROM END OF THE GUIDE PIN AND REQUESTED A 7.0MM X 105MM CANNULATED SCREW 16MM THREAD STAINLESS STEEL TO BE OPENED FOR USE. DURING INSERTION OF THE 105MM SCREW, IT WAS NOTED THAT THE 105MM SCREW WAS APPROX 10MM TOO LONG. A 7.0MM X 95MM CANNULATED SCREW 16MM THREAD WAS THEN REQUESTED AND INSERTED OVER THE GUIDE PIN. THE 95MM SCREW WAS NOTED TO BE OF THE CORRECT LENGTH. FINALLY, THE CHS IMPLANTATION WAS THEN COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO INJURY TO THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11444223 ↗
• MalfunctionApr 6, 2020Failure to Calibrate; Failure to Calibrate

  IT WAS REPORTED THAT DURING PROCEDURE DR. USED THE DEPTH GAUGE AND THEN INSERTED SCREWS. ALL THE SCREWS WERE TOO LONG. DR. SWITCHED TO SHORTER SCREWS AND AFTER CASE, THE 6.5/8.0MM DIR MEAS GAUGE WAS INSPECTED WITH CLEAN GUIDE PINS AND CORRECTLY MEASURE SCREWS. IT WAS FOUND THAT NUMBERS ON THE DEPTH GAUGE WERE 5MM OFF. ITEM IS NOT CALIBRATED CORRECTLY TO READ AT THE END OF THE PIN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9927475 ↗