HEALIX AWL/TAP 222224Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705007714), received between Nov 23, 2022 and Mar 17, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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 18, 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 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FILE IS A REVIEW OF THE FOLLOWING JOURNAL ARTICLE: ORLETSKII, A., ET AL (2022) SURGICAL TREATMENT OF POST-TRAUMATIC INSTABILITY OF THE SHOULDER JOINT IN ATHLETES. N. N. PRIOROV HERALD OF TRAUMATIC SURGERY AND ORTHOPEDICS, VOL. 29, NO. 1, PAGES 5-18 (RUSSIA). THE STUDY EMPHASIZES ON THE ASSESSMENT OF RESULTS AND COMPLICATIONS DURING THE POSTOPERATIVE PERIOD, SURGICAL INTERVENTION TIME, AND TECHNICAL DIFFICULTIES AND NUANCES DURING THE PERFORMANCE OF THE ARTHROSCOPIC LATARJET PROCEDURE AMONG PROFESSIONAL ATHLETES AND AMATEUR ATHLETES WITH POST-TRAUMATIC SHOULDER JOINT DEFECTS. THE PATIENTS EVALUATED ON COURSE OF THIS STUDY: 50 PATIENTS . THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: ARTHROSCOPIC LATARJET PROCEDURE. THE DEVICES INVOLVED WERE: HEALIX 5.5 AWL/TAP. COMPLICATIONS DESCRIBED: 1 UNKNOWN PATIENT EXPERIENCED AXILLARY NERVE INJURY, WHICH RESOLVED AFTER 3 WEEKS OF ADDITIONAL TREATMENT. 1 PATIENT EXPERIENCED RECURRENT DISLOCATION. A COPY OF THIS LITERATURE ARTICLE IS ATTACHED TO THIS MEDWATCH REPORT.

  Patient problems: Joint Laxity; Nerve Damage

  MAUDE report 16565217 ↗
• MalfunctionNov 23, 2022Material Deformation; Material Deformation

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE HEALIX 5.5 AWL/TAP WAS BENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15857037 ↗