NA 03.010.062Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982067357), received between Mar 30, 2018 and Mar 30, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Off-Label Use” (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.

• InjuryMar 30, 2018Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT A SURGEON HAD A CASE INVOLVING A FEMORAL SHAFT FRACTURE ON (B)(6) 2018 IN WHICH THE RETROGRADE AND ANTEROGRADE FEMORAL SYSTEM WAS USED. UPON ARRIVING INTO THE ROOM, THE SALES CONSULTANT ASKED THE SURGICAL TECH TO GATHER ALL OF THE INSTRUMENTATION OUT OF OUR TRAY AND PLACE THE INSTRUMENTATION ON THE BACK TABLE. SALES CONSULTANT TOLD THE SURGICAL TECH TO GET THE 4.2MM DRILL BIT, BUT UNFORTUNATELY THE SURGICAL TECH REACHED OUT AND TOOK THE 5.0MM DRILL BIT. THE 5.0MM DRILL BIT WAS TAKEN OUT AND LOADED INTO THE DRILL. ONCE LOADED INTO THE DRILL, THE SPECIFIC SIZE OF THE DRILL COULDN¿T BE DETERMINED BECAUSE THE DRILL COVERED IT UP. THIS MISTAKE WAS NOT REALIZED UNTIL A MEASUREMENT WAS TAKEN FOR THE SCREW LENGTH. UPON REALIZING THE MISTAKE, THE SURGEON DECIDED TO DRILL AN ADDITIONAL SCREW HOLE THROUGH THE ANTERIOR/POSTERIOR HOLE. A TOTAL OF 3 OUT OF 4 DISTAL SCREW HOLES WERE UTILIZED IN THE IMPLANT. IMPLANTED SCREWS WERE NOT MALFUNCTIONED OR COMPROMISED. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT OUTCOME WAS SATISFACTORY. CONCOMITANT PART: SCREWS (UNKNOWN PART AND LOT NUMBER, QUANTITY THREE). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 7384944 ↗