NA 214640Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10886705004218), received between Jul 23, 2018 and Jun 2, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE ARTHRO CLEVERHOOK-RIGHT DEVICE BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25365554 ↗
• MalfunctionMar 11, 2025Degraded; Degraded

  EVENT DESCRIPTION UPDATE: IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE ARTHRO CLEVERHOOK-RIGHT DEVICE WAS DULL, AND IT WOULD NOT PASS THROUGH TENDON. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21577299 ↗
• MalfunctionJun 10, 2024Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CLEVER HOOK - RIGHT DEVICE JAW WAS BROKEN WHEN THE SURGEON PICKED IT UP TO USE IT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19497433 ↗
• MalfunctionMay 24, 2023Break; Break

  THIS IS REPORT 2 OF 5 FOR (B)(4). IT WAS REPORTED THROUGH IN-HOUSE DISTRIBUTION THAT WHILE ORGANIZING THE SHELVES, IT WAS OBSERVED THAT THE CLEVER HOOK - RIGHT DEVICE WAS BROKEN. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16994557 ↗
• MalfunctionMay 24, 2023Break; Break

  THIS IS REPORT 1 OF 5 FOR (B)(4). IT WAS REPORTED THROUGH IN-HOUSE DISTRIBUTION THAT WHILE ORGANIZING THE SHELVES, IT WAS OBSERVED THAT THE CLEVER HOOK - RIGHT DEVICE WAS BROKEN. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16994548 ↗
• MalfunctionDec 28, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE TIP ON THE CLEVER HOOK - RIGHT DEVICE WAS BENT WHILE THE SURGEON WAS PASSING THE SUTURES THROUGH. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. 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 16061021 ↗
• MalfunctionDec 28, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE TIP ON CLEVER HOOK - RIGHT DEVICE WAS BENT. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. 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 16060699 ↗
• MalfunctionNov 14, 2022Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT PREOPERATIVELY TO AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE CLEVER HOOK - RIGHT DEVICE WAS BROKEN. 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 15791691 ↗
• MalfunctionMay 20, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(4) THAT PREOPERATIVELY TO AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE ARTHRO CLEVERHOOK-RIGHT DEVICE WAS BROKEN. 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 14460946 ↗
• MalfunctionJan 11, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A SHOULDER ARTHROSCOPY ROTATOR CUFF REPAIR PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE CLEVER HOOK DEVICE DID NOT CLOSE PROPERLY. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT IT WAS NOT POSSIBLE TO OPEN OR CLOSE THE JAWS ON THE DEVICE AS THE INTERNAL SHAFT WAS FOUND TO BE LOOSE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 10 TO 15 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11147095 ↗
• MalfunctionJun 29, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ARTHRO CLEVERHOOK-RIGHT *EA HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE LOWER JAW ON THE DEVICE WAS LOOSE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF ANY 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 10206441 ↗
• MalfunctionDec 9, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT DURING A ROTATOR CUFF REPAIR THE SURGEON NOTICED THAT THE TIP OF THE ARTHRO CLEVERHOOK-RIGHT *EA WAS BENT. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9437634 ↗
• MalfunctionSep 23, 2019Material Twisted/Bent; Material Twisted/Bent

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE CUSTOMER VIA PHONE THAT DURING A SHOULDER REPAIR THE CUSTOMER'S CLEVER HOOK-LEFT AND CLEVER HOOK-RIGHT WERE BENT HALFWAY DOWN THE SHAFT. THE CONDITION OF THE DEVICES WAS NOTICED BEFORE BEING USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH OTHER LIKE-DEVICES, AND THERE WAS NO HARM TO THE PATIENT OR DELAYS TO THE CASE. THE CUSTOMER WAS NOT PRESENT FOR THE CASE, THEREFORE COULD NOT PROVIDE ANY ADDITIONAL INFORMATION OR LOT NUMBERS FOR THE DEVICES, BUT STATED THE DEVICES ARE LESS THAN A YEAR OLD. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. 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 9103785 ↗
• MalfunctionSep 13, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) VIA E-MAIL THAT DURING SHOULDER ARTHROSCOPY ROTATOR CUFF REPAIR, INSTRUMENTS WERE FOUND TO BE BROKEN - JAW OF INSTRUMENT NOT OPENING OR CLOSING. INITIALLY WORKING WELL, BUT AFTER SEVERAL PASSING OF SUTURE THROUGH TENDON THAT WAS DIFFICULT, JAW OF INSTRUMENT WOULD NOT OPEN OR CLOSE. ALTERNATE DEVICE SOURCED WITH A ONE MINUTE DELAY TO PROCEDURE. NO AE TO PATIENT. THERE WAS A DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. 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: Not Applicable

  MAUDE report 9042762 ↗
• MalfunctionApr 8, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE THAT DURING AN UNKNOWN PROCEDURE THEY NOTICED THAT THE CLEVERHOOK HANDLE WAS GETTING STUCK. THE PROCEDURE WAS COMPLETED WITH A SECOND DEVICE WITH NO DELAY TO THE CASE. THE AFFILIATE DID NOT REPORT ANY PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8492056 ↗
• MalfunctionOct 26, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED THAT PRIOR TO A SHOULDER PROCEDURE THE SHAFT COMPONENT ON THE CUSTOMER'S CLEVER HOOK RIGHT THAT OPENS AND CLOSES THE JAW WAS CRACKED. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REPRESENTATIVE WAS NOT PRESENT FOR THE CASE AND COULD NOT PROVIDE ANY FURTHER INFORMATION. THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8008699 ↗
• MalfunctionSep 24, 2018Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, A CLEVERHOOK RIGHT HAD A BROKEN TIP. A NEW CLEVERHOOK HAS BEEN USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FOUR MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7902776 ↗
• MalfunctionJul 31, 2018Break; Break

  THE SALES REP REPORTED THAT HE WAS INFORMED THAT THE DEVICE BROKE DURING THE PROCEDURE; THE SALES REP IS UNSURE HOW IT BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO DELAY AND NO CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7736847 ↗
• MalfunctionJul 23, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE CLEVER HOOK RIGHT DEVICE WAS BROKEN AND WILL NOT WORK. IT WAS REPORTED THAT THE CLINIC USED THEM RARELY AND HAD A GOOD STERILIZATION PROCEDURE. THE INSTRUMENT WAS ABOUT ONE YEAR OLD AND HAS BEEN USED LESS THAN TEN TIMES ACCORDING TO THE CLINIC. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. IT WAS NOT REPORTED IF THERE WERE ANY 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 7710047 ↗