NA 214616Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705003990), received between Aug 23, 2018 and Aug 6, 2024 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 6, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ARTHRO CROCHET HOOK DEVICE WAS BROKEN AND THROWN OUT. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19917604 ↗
• MalfunctionNov 15, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT ON AN UNKNOWN DATE IT WAS OBSERVED THAT THE SHAFT OF THE ARTHRO CROCHET HOOK *EA DEVICE WAS BENT AND NOTED THAT THERE WAS A RISK OF INTRAOPERATIVE DAMAGE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18142879 ↗
• MalfunctionJan 3, 2023Material Deformation; Appropriate Device Problem Term/Code Not Available; Material Deformation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT THE CROCHET HOOK DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE TIP ON THE DEVICE WAS BENT. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16091600 ↗
• MalfunctionAug 23, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT WHILE SETTING UP FOR A ROTATOR CUFF PROCEDURE, HE NOTICED THAT THE TIP ON THE CUSTOMER'S CROCHET HOOK WAS BROKEN OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7808699 ↗