HEALIX TRANSTEND 222273Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705008186), received between Jan 9, 2020 and Dec 2, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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.

• MalfunctionDec 2, 2024Break; Break

  IT WAS REPORTED THAT DURING A QUAD TENDON PROCEDURE, IT WAS DISCOVERED THAT THE PRC AWL / TAP DEVICE BROKE IN HALF. IT WAS REPORTED THAT THE BROKEN TAP WAS PUT ON THE CHUCK TO COMPLETE THE SURGERY. AS A RESULT, THERE WAS A DELAY TO THE SURGICAL PROCEDURE; HOWEVER, THE DURATION OF THE DELAY WAS NOT SPECIFIED. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20818897 ↗
• MalfunctionOct 2, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE SHAFT ON THE HEALIX TRANSTEND AWL/TAP DEVICE WAS BENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 17855502 ↗
• MalfunctionFeb 22, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE HEALIX TRANSTEND AWL/TAP DEVICE WAS BENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16419164 ↗
• MalfunctionJan 9, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT THE TIP OF THE HEALIX TRANSTEND AWL/TAP IS BENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9569619 ↗