NA 03.010.028Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982067029), received between Jan 6, 2017 and Mar 2, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE FEMORAL RECON NAIL SLEEVES (GOLD RECON) AND AN OPENING DRILL BIT WERE BEING HELD BY SPD BECAUSE OF UNCERTAINTY REGARDING THEIR CLEANLINESS. THE SPD MANAGER REPORTED FINDING RESIDUE INTERNALLY ON THE GOLD SLEEVES AND THE DRILL BIT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24490398 ↗
• MalfunctionMar 2, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE FEMORAL RECON NAIL SLEEVES (GOLD RECON) AND AN OPENING DRILL BIT WERE BEING HELD BY SPD BECAUSE OF UNCERTAINTY REGARDING THEIR CLEANLINESS. THE SPD MANAGER REPORTED FINDING RESIDUE INTERNALLY ON THE GOLD SLEEVES AND THE DRILL BIT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24490395 ↗
• MalfunctionJan 19, 2018Break; Break

  IT WAS REPORTED THAT AN OPEN DRILL BIT BROKE DURING A LATERAL ENTRY FEMORAL NAIL ON (B)(6) 2017. THE DRILL BIT WAS REPORTED TO HAVE BROKEN AS THE SURGEON WAS ATTACHING IT TO THE REAMER. THE PART THAT ATTACHES TO THE REAMER BROKE OFF CAUSING AN ESTIMATED TWO (2) MINUTE DELAY IN SURGERY AS THE SURGEON SWITCHED OVER TO A NEW DRILL BIT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ANOTHER DRILL BIT. THE PATIENT OUTCOME WAS REPORTED AS PERFECT. CONCOMITANT DEVICES REPORTED: 3.2 MM GUIDE WIRE (PART 357.399, LOT UNKNOWN, QUANTITY 1). 22.0 MM/17.0 MM PROTECTION SLEEVE (PART 357.410, LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7206334 ↗
• MalfunctionJan 6, 2017Break; Break

  IT WAS REPORTED THAT DURING A FEMORAL INTRAMEDULLARY NAIL PROCEDURE ON (B)(6) 2016, AS THE SURGEON WAS DRILLING INTO THE CANAL STUMP OF THE FEMUR THE CONNECTION TO THE DRILL BIT BROKE AT THE STEP DOWN WHERE THE DRILL BIT IS CONNECTED TO THE STRYKER SYSTEM 7 DRILL (WHICH IS AT THE COUPLING END OF THE DRILL BIT). A BACKUP DRILL WAS AVAILABLE AND THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT FURTHER COMPLICATIONS. THERE WAS NO SURGICAL TIME DELAY AND NO PATIENT HARM REPORTED. THE PATIENT STATUS WAS STABLE. THIS COMPLAINT CONTAINS ONE DEVICE. THIS REPORT IS 1 OR 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6230711 ↗