HEALICOIL 72201915Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010610607), received between Oct 3, 2018 and Aug 25, 2025 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGERY, WHEN THE GUIDE WAS PLACED AND TAPPED, THE TAPERED AWL BROKE OFF. THE BROKEN PARTS WERE REMOVED FROM THE PATIENT. THE SURGERY WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22891854 ↗
• MalfunctionJun 4, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER CUFF RECONSTRUCTION PROCEDURE, WHEN THE ANCHOR WAS BEING INITIALLY PLACED, THE AWL TAPERED IMPACTOR BROKE, DAMAGING IT. ALL THE PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22145539 ↗
• MalfunctionOct 1, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE AWL TAPERED WAS BROKEN. THE PROCEDURE WAS COMPLETED USING THE SAME FAULTY DEVICE. THERE WAS A SURGICAL DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20349421 ↗
• MalfunctionJun 10, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER AND CUFF REPAIR, WHEN INTRODUCING THE AWL TAPERED 3.8MM ANCHOR PUNCTOR AND IMPACTING TO MAKE THE INITIAL ANCHOR, THE HEAD TO THE ANCHOR BROKE. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19498362 ↗
• MalfunctionOct 26, 2023Break; Break

  IT WAS REPORTED THAT DURING SET UP, THE AWL TAPERED DEVICE WAS BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY USING THE REPORTED DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18014335 ↗
• MalfunctionJun 20, 2023Break; Break

  IT WAS REPORTED THAT DURING A BICEPS RECONSTRUCTION, THE AWL TAPERED INITIATOR PRESENTED A SMALL FISSURE, AND WHEN STARTING THE IMPACTION THE ANCHOR INITIATOR BROKE COMPLETELY, THE SURGEON CONTINUED IMPACTING AND REMOVED THE INITIATOR WITH PLIERS TO INTRODUCE THE ANCHOR. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE. NO DELAY OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17166578 ↗
• InjuryOct 11, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE DISTAL TIP OF THE AWL TAPERED SHAFT BROKE WHEN IT WAS HAMMERED INTO THE HUMERAL HEAD. ALL THE PIECES WERE RETRIEVED FROM THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED; HOWEVER, A NON-SIGNIFICANT DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15578504 ↗
• InjuryMay 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TENDON TRANSPOSITION PROCEDURE, THE TAPERED AWL WAS DISASSEMBLED IN THE SURGEON'S HAND WHEN IT WAS TRIED TO REMOVE IT FROM THE PATIENT. FORCE WAS USED AND IT STILL DID NOT COME OFF THE BONE, REQUIRING THE USE OF PLIERS AND A HAMMER TO REMOVE IT. ALL THE PIECES WERE REMOVED FROM THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO SURGICAL DELAY NOR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14438545 ↗
• MalfunctionMar 27, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP DETACHED FROM THE HANDLE AT THE FIRST HAMMER. THEY FIXED THE INSTRUMENT WITH TAPE AND FINISHED THE SURGERY. THE TIP BROKE INSIDE THE PATIENT AND ALL THE PIECES WERE REMOVED FROM THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8455941 ↗
• MalfunctionNov 27, 2018Break

  IT WAS REPORTED THAT DURING A SURGERY, THE TIP OF INSTRUMENT BROKE OFF DURING USE. THERE WAS NOT DELAY AND WAS NOT BACKUP AVAILABLE, THAT PORTION OF THE PROCEDURE WAS THEREFORE ABORTED. ACCORDING TO THE CUSTOMER KNOWLEDGE THE PIECE WAS NOT REMOVE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8105515 ↗
• MalfunctionOct 3, 2018Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHILE TAPPING THE GOLD AWL INTO THE BONE, THE PLASTIC BLACK CAP ON THE TOP OF THE AWL BROKE OFF. ALL OF THE PIECES WERE REMOVED AND SPADE DRILL WAS USED TO FINISH BONE PREP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7931885 ↗