HEALIX ADVANCE 222326Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886705021802), received between Jun 3, 2019 and Oct 5, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 5, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A QUADRICEP TENDON REPAIR PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE HEALIX ADVANCE 4.0MM DRILL BIT DEVICE CREATED SOME METAL DEBRIS WHILE MAKING A STARTER HOLE FOR THE ANCHOR. THERE WERE FRAGMENTS GENERATED BUT REMOVED EASILY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12577923 ↗
• MalfunctionOct 28, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED VIA COMPLAINT SUBMISSION TOOL THAT DURING A SHOULDER REPAIR, IT WAS NOTED THAT 4.0 MM HEALIX DRILL SEEMED DULL. IT WAS REPLACED WITH A READILY AVAILABLE REPLACEMENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT HARM OR SURGICAL DELAY. THE DRILL BIT WAS MISTAKENLY THROWN INTO THE SHARPS BIN THINKING IT WAS AT END OF LIFE AND COULD NOT BE RECOVERED. REP WAS NOT PRESENT FOR THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10750884 ↗
• MalfunctionJul 30, 2020Degraded; Degraded

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP VIA PHONE THAT TWO 4.0 MM HEALIX DRILL WERE FOUND DULL DURING INSPECTION. NO PROCEDURE OR PATIENT WAS INVOLVED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10343480 ↗
• MalfunctionJul 30, 2020Degraded; Degraded

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP VIA PHONE THAT TWO 4.0 MM HEALIX DRILL WERE FOUND DULL DURING INSPECTION. NO PROCEDURE OR PATIENT WAS INVOLVED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10343479 ↗
• MalfunctionJul 7, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING INSPECTION IT WAS NOTICED THAT THE 4.0MM HEALIX DRILL WAS DULL. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10240670 ↗
• MalfunctionJun 3, 2019Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACHILLES REPAIR PROCEDURE, IT WAS OBSERVED THAT THE SALES REP'S 4 MM HEALIX DRILL TIP WAS DULL. THE CASE WAS COMPLETED WITH THIS DEVICE WITH NO PATIENT HARM OR DELAY. THE LASER LINES WERE FADED AND THE SALES REP COULD ONLY PROVIDE A PARTIAL LOT. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8662692 ↗