NA 214641Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886705004225), received between Jul 18, 2018 and Jun 1, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THE ARTHRO CLEVERHOOK-LEFT DEVICE FAILED TO PENETRATE THE TISSUE. 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 25355749 ↗
• MalfunctionJan 6, 2026Difficult to Open or Close; Unintended Movement

  IT WAS REPORTED THAT THE CLEVER HOOK OF THE ARTHRO CLEVERHOOK-LEFT DEVICE WAS NOT OPENED. DURING IN-HOUSE ENGINEERING EVALUATION OF THE DEVICE, IT WAS OBSERVED THAT THE LOWER JAW WAS LOOSE. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973316 ↗
• MalfunctionMay 29, 2025Difficult to Open or Close; Unintended Movement; Difficult to Open or Close; Unintended Movement

  IT WAS REPORTED THAT DURING PRE-SURGERY FOR SHOULDER SCOPE PROCEDURE, IT WAS OBSERVED THAT THE ARTHRO CLEVERHOOK-LEFT DEVICE WAS BROKEN AND THE DEVICE JAWS DID NOT OPEN AND CLOSE PROPERLY ANYMORE. 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 22104019 ↗
• MalfunctionMay 15, 2024Loose or Intermittent Connection; Use of Device Problem; Loose or Intermittent Connection; Use of Device Problem

  IT WAS REPORTED BY THE AFFILIATE IN AUSTRALIA THAT DURING LOANER KIT INSPECTION, IT WAS OBSERVED THAT THE ARTHRO CLEVERHOOK DEVICE WAS DAMAGED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD WEAR MARK, THESE WEAR MARKS WERE FOUND ALONG THE DEVICE, ALSO THE ETCH MARKS ARE FADED. UPON REVIEWING THE JAW OF THE DEVICE IT WAS NOTED THAT IT IS LOOSE. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19324218 ↗
• MalfunctionApr 30, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED BY THE SALES REP FROM SWITZERLAND THAT ON 4/18/2024 THE ARTHRO CLEVERHOOK DEVICE WAS BROKEN, THE DEVICE JAW WAS BROKEN AND DID NOT WORK PROPERLY ANYMORE. THE DEVICE WAS NEW. THERE WAS NO REPORTS OF DELAY REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212203 ↗
• MalfunctionApr 25, 2024Loose or Intermittent Connection; Difficult to Open or Close; Loose or Intermittent Connection; Difficult to Open or Close

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THE ARTHRO CLEVERHOOK-LEFT DEVICE THE MOVEMENT OF THE DEVICE FOR LEFT IN QUESTION BECAME A LITTLE STIFF IN THE MIDDLE OF USE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE JAW WAS LOOSE. 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 19180562 ↗
• MalfunctionOct 16, 2023Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  IT WAS REPORTED BY THE SALES REP IN AUSTRALIA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023 THE ARTHRO CLEVERHOOK-LEFT DEVICE HAD A TEAR AND A BEND ON THE TIP OF THE INSTRUMENT. 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 17939523 ↗
• MalfunctionMay 24, 2023Break; Break

  THIS IS REPORT 5 OF 5 FOR (B)(4). IT WAS REPORTED THROUGH IN-HOUSE DISTRIBUTION THAT WHILE ORGANIZING THE SHELVES, IT WAS OBSERVED THAT THE CLEVER HOOK - LEFT 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 16995452 ↗
• MalfunctionMay 5, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE CLEVER HOOK - LEFT DEVICE WAS BENT NEAR THE JAW. 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 16879207 ↗
• MalfunctionNov 24, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE ARTHRO CLEVERHOOK-LEFT 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 12869699 ↗
• MalfunctionMar 9, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE CLEVER HOOK, LEFT DEVICE WAS BENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11447245 ↗
• MalfunctionJul 30, 2020Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR, IT WAS OBSERVED THAT THE TIP OF THE CLEVER HOOK LEFT WAS BENT AND DULL. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10343412 ↗
• MalfunctionFeb 21, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN UNKNOWN PROCEDURE THE EXPRESSEW III SUTURE PASSER W/O HOOK AND THE CLEVER HOOK - LEFT WERE BROKEN. THE JAWS OF THE DEVICES ARE NOT OPENING AND CLOSING. ANOTHER DEVICES WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THESE PRODUCTS WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9739693 ↗
• MalfunctionDec 12, 2019Difficult to Open or Close; Material Twisted/Bent; Difficult to Open or Close; Material Twisted/Bent

  IT WAS REPORTED BY THE AFFILIATE VIA CST THAT DURING A ROTATOR CUFF REPAIR THE JAW OF THE ARTHRO CLEVERHOOK-LEFT WAS NOT OPENING AS IT SHOULD AND THE OPENING MECHANISM IS SLIGHTLY BENT. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9460040 ↗
• MalfunctionSep 23, 2019Material Twisted/Bent; Material Twisted/Bent

  THIS IS REPORT 2 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 9103786 ↗
• MalfunctionOct 29, 2018Corroded; Corroded

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT AFTER THE FIRST WASHING-PROCESS BUT BEFORE STEAM STERILISATION THE CSSD REFUSED TO FURTHER RE-PROCESS THE INSTRUMENT AS INSTRUMENT´S ETCHING WAS RUSTY. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8016683 ↗
• MalfunctionAug 30, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CLEVER HOOK OPENER WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT. 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 7831911 ↗
• MalfunctionAug 23, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING PRE-SURGERY, IT WAS OBSERVED THAT THE CLEVER HOOK LEFT DEVICE WAS BROKEN. 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. THE EXACT DATE OF THE EVENT WAS UNKNOWN. 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 7809768 ↗
• MalfunctionAug 22, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE TIP OF THE CLEVER HOOK LEFT DEVICE SNAPPED OFF. THE PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT. 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 7804956 ↗
• MalfunctionAug 2, 2018Break; Break

  THE INSTRUMENT WAS NEW. THE SURGEON HAS USED CLEVERHOOK ALOT BEFORE. THE "MOUTH" OF THE INSTRUMENT BROKE AND COULD NOT CLOSE PROPERLY. UNKNOWN SURGERY DATE. WITH SAME LIKE PRODUCT, EXTENDED THE SURGERY 10 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7744246 ↗
• MalfunctionJul 18, 2018Break; Defective Device; Material Twisted/Bent; Break; Defective Device; Material Twisted/Bent

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE CLEVER HOOK LEFT DEVICE WAS DAMAGED (BENT/BROKEN). 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. THE EXACT DATE OF THE EVENT WAS UNKNOWN. 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 7700257 ↗