NA 214600Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10886705003839), received between Jul 19, 2018 and Aug 12, 2026 — classified as 42 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (27 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Break; Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50224400 ↗
• MalfunctionFeb 20, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THAT THE ARTHRO GRASPER PEN STR DEVICE JAWS FAILED TO STAY CLOSED. 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 24405374 ↗
• MalfunctionSep 5, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE ARTHRO GRASPER PEN STR EA DEVICE WAS BROKEN. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22982932 ↗
• MalfunctionJul 11, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A BANKART REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE ARTHRO GRASPER PEN STR DEVICE WOULD NO LONGER OPEN OR CLOSE. ANOTHER DEVICE HAD TO BE OPENED TO FINISH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22480098 ↗
• MalfunctionJun 9, 2025Difficult to Open or Close; Mechanical Jam; Difficult to Open or Close; Mechanical Jam

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS FOUND THAT THE ARTHRO GRASPER PEN STR *EA DEVICE HAD A STUCK CAPTURE POINT; WHEN THE TRIGGER WAS PULLED, THE GRASPER DID NOT MOVE IN AND OUT CONSISTENTLY AND FAILED TO CLOSE COMPLETELY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22168168 ↗
• MalfunctionFeb 20, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ARTHRO GRASPER PEN STR DEVICE WAS MALFUNCTIONING AND WOULD NOT CLOSE PROPERLY. 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21420550 ↗
• MalfunctionDec 27, 2024Degraded; Material Twisted/Bent; Degraded; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE ARTHRO GRASPER PEN STR DEVICE BLUE HOOK NOT PASSING THROUGH TENDON. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE TIP WAS DEFORMED. 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 21025845 ↗
• MalfunctionFeb 1, 2024Break; Difficult to Open or Close; Break; Difficult to Open or Close

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER SCOPE PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE PENETRATING GRASPER STRAIGHT WAS BROKEN; AND THAT THE CAPTURE POINT OF THE BIRD BEAK WOULD NOT CLOSE. 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 18622977 ↗
• MalfunctionAug 24, 2023Break; Difficult to Open or Close; Break; Difficult to Open or Close

  IT WAS REPORTED BY SALES REP THAT AT THE END OF A SHOULDER BANKART REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE PENETRATING GRASPER STRAIGHT DEVICE BROKE AND WAS UNABLE TO OPEN/CLOSE PROPERLY. IT WAS UNKNOWN IF AND 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 17615565 ↗
• MalfunctionAug 3, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY THE SALES REP THAT DURING SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6)2023, IT WAS OBSERVED THAT THE PENETRATING GRASPER STRAIGHT DEVICE WAS NOT CLOSING; AND THAT IT SEEMED LIKE THE HANDLE MECHANISM HAD DISENGAGED AND HAD NO TENSION. A DIFFERENT ANGLE WAS USED TO COMPLETE PROCEDURE. THERE WERE NO SURGICAL DELAY NOR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17452784 ↗
• MalfunctionJul 10, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE SPRING ON THE PENETRATING GRASPER STRAIGHT DEVICE BROKE; AND THEREFORE, WAS NOT CLOSING. IT WAS UNKNOWN IF AND 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 17291089 ↗
• MalfunctionApr 19, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER SCOPE PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE PENETRATING GRASPER STRAIGHT DEVICE WAS FOUND BENT AND NOT FLUSHED WITH THE NOSE OF THE DEVICE. 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 16772934 ↗
• MalfunctionNov 21, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE PENETRATING GRASPER STRAIGHT DEVICE 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 15837444 ↗
• MalfunctionNov 10, 2022Material Deformation; Material Deformation

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING IN THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE SURGEON BENT TWO PENETRATING GRASPER DEVICES WHILE TRYING TO REPAIR THE LABRUM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15775250 ↗
• MalfunctionNov 1, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN SURGERY ON (B)(6)2022 , IT WAS OBSERVED THAT THE PENETRATING GRASPER STRAIGHT DEVICE WAS DIFFICULT TO OPEN OR CLOSE; AND THEREFORE, UNABLE TO USE. 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 15708955 ↗
• MalfunctionAug 3, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE JAW ON THE PENETRATING GRASPER STRAIGHT DEVICE WAS NOT OPENING. 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 15156796 ↗
• MalfunctionApr 22, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE TIP OPENING MECHANISM ON THE ARTHRO GRASPER PEN STR DEVICE WAS NOT WORKING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS PIECE OF INSTRUMENTATION IS BAD BECAUSE THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14187227 ↗
• MalfunctionApr 13, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE PENETRATING GRASPER STRAIGHT DEVICE WAS BENT. 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 14106112 ↗
• MalfunctionDec 7, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE TIP ON THE ARTHRO GRASPER PEN STR DEVICE BROKE. THERE WERE NO FRAGMENTS LEFT IN THE BODY OF THE PATIENT. 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 12955348 ↗
• MalfunctionOct 19, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY THE SALES REP THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE JAWS ON THE ARTHRO GRASPER PEN STR DEVICE WAS NOT ARTICULATING WITH THE HANDPIECE. 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 12658517 ↗
• MalfunctionMar 2, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE PENETRATING GRASPER STRAIGHT DEVICE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11398815 ↗
• MalfunctionOct 8, 2020Difficult to Open or Close

  IT WAS REPORTED VIA COMPLAINT SUBMISSION TOOL THAT DURING A SHOULDER REPAIR, THE SURGEON WAS USING THE PENETRATING GRASPER STRAIGHT TO PASS SUTURE THROUGH THE ROTATOR CUFF. HE TRIED TO OPEN THE JAWS, HEARD A POP, AND THE JAWS WOULD NOT OPEN. UPON INVESTIGATION, THE JAWS WOULD NOT OPEN ANY LONGER. THE INSTRUMENT WAS REPLACED WITH A READILY AVAILABLE REPLACEMENT AND THE CASE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT HARM OR SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10652824 ↗
• MalfunctionOct 8, 2020Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED VIA COMPLAINT SUBMISSION TOOL THAT DURING A SHOULDER REPAIR, THE SURGEON WAS USING THE PENETRATING GRASPER STRAIGHT TO PASS SUTURE THROUGH THE ROTATOR CUFF. HE TRIED TO OPEN THE JAWS, HEARD A POP, AND THE JAWS WOULD NOT OPEN. UPON INVESTIGATION, THE JAWS WOULD NOT OPEN ANY LONGER. THE INSTRUMENT WAS REPLACED WITH A READILY AVAILABLE REPLACEMENT AND THE CASE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT HARM OR SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10652785 ↗
• MalfunctionJan 14, 2020Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE BOTH THEIR PENETRATING GRASPER STRAIGHT AND PENETRATING GRASPER 35 DEGREE UP WILL NOT OPEN OR CLOSE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ANGLE DEVICE WITH NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THE DEVICES WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9587209 ↗
• MalfunctionNov 22, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT THIS PENETRATING GRASPER STRAIGHT BROKE DURING AN UNKNOWN PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCE OR SURGICAL DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9364516 ↗