NA 214601Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 10886705003846), received between Jul 10, 2018 and Sep 2, 2026 — classified as 56 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (34 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 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Device-Device Incompatibility; Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50560833 ↗
• MalfunctionFeb 13, 2026Difficult to Open or Close

  IT WAS REPORTED THAT THE JAWS ON THE ARTHRO GRASPER PEN 35 UP DID NOT OPEN. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. 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 (B)(6) 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337788 ↗
• MalfunctionJan 26, 2026Difficult to Open or Close; Material Deformation

  IT WAS REPORTED THAT DURING A LOAN KIT INSPECTION THE JAW OF THE ARTHRO GRASPER PEN 35 UP FAILED TO CLOSE, AND EXTENDING THE HANDLES CAUSED AN INTERNAL MECHANISM TO BEND OUT OF ALIGNMENT. THE EVENT WAS NOT RELATED TO 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 24177670 ↗
• MalfunctionJul 15, 2025Difficult to Open or Close; Material Deformation; Difficult to Open or Close; Material Deformation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE ARTHRO GRASPER PEN 35 UP DEVICE, WHILE USING THE CLEVER HOOK, AFTER PASSING THROUGH THE TENDON IT WAS IMPOSSIBLE TO OPEN THE JAW AND OLD THE SUTURE. WE OPENED A SECOND TRAY AND THE NEW INSTRUMENT WORKED PERFECTLY. ON CLOSE INSPECTION OF THE 2 PASSERS IT WAS FOUND THAT THIS ONE WAS BENT REDUCING THE ABILITY TO OPEN AND CLOSE PROPERLY. ANOTHER 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 22506787 ↗
• MalfunctionJan 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE ARTHRO GRASPER PEN 35 UP EA DEVICE PIN THAT CONTROLS THE JAW WAS DISLODGED, TANGLING THE SUTURE WHEN USED THROUGH THE SCOPE PORTALS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21229908 ↗
• MalfunctionJun 4, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING PRE SURGERY FOR AN UNSPECIFIED SURGICAL PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT WHEN THE MOVEMENT OF THE ARTHRO GRASPER PEN 35 UP DEVICE WAS CHECKED, IT WAS CONFIRMED THAT THE CATCHING PART COULD NOT BE COMPLETELY CLOSED. ACCORDING TO THE REPORTER, IT CLEARLY DID NOT CLOSE AND WHEN THE SURGEON TOUCHED IT WITH HIS FINGER, IT WAS UNEVEN BECAUSE IT WAS NOT CLOSED. 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 19459618 ↗
• MalfunctionApr 30, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP IN ESTONIA THAT DURING AN UNSPECIFIED SURGERY ON (B)(6) 2024, IT WAS OBSERVED THAT THE ARTHRO GRASPER PEN 35 UP DEVICE HAD A BENT TIP. 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 19211575 ↗
• MalfunctionApr 25, 2024Break; Difficult to Open or Close; Break; Difficult to Open or Close

  IT WAS REPORTED THAT DURING SUBSCAPULARIS REPAIR PROCEDURE, IT WAS OBSERVED THAT THE PENETRATING GRASPER 35° UP DEVICE WAS BROKEN; AND THAT THE JAWS WOULD NOT CLOSE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH AN UNSPECIFIED DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19183262 ↗
• MalfunctionOct 20, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2023 THE ARTHRO GRASPER PEN 35 UP DEVICE UP JAW WAS NOT CLOSING PROPERLY. 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 17977212 ↗
• MalfunctionJun 5, 2023Difficult to Open or Close; Appropriate Device Problem Term/Code Not Available; Difficult to Open or Close; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT THE PENETRATING GRASPER 35° UP DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE UPPER JAW ON THE DEVICE WOULD NOT OPEN COMPLETELY. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17063465 ↗
• MalfunctionFeb 9, 2023Device-Device Incompatibility; Difficult to Open or Close; Device-Device Incompatibility; Difficult to Open or Close

  THIS IS REPORT 2 OF 2 FOR PC-(B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6)2023 IT WAS OBSERVED THAT THE PENETRATING GRASPER 35° UP DEVICE WAS NOT ABLE TO GRASP SUTURE AND NOT OPENING UP. 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 16340853 ↗
• MalfunctionNov 10, 2022Material Deformation; Material Deformation

  THIS IS REPORT 1 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15774476 ↗
• MalfunctionOct 20, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY SALES REP VIA EMAIL THAT DURING A BICEPS TENODESIS PROCEDURE ON (B)(6) 2022 IT WAS OBSERVED THAT THE PENETRATING GRASPER 35° UP WAS STUCK OPEN IN A PATIENT¿S SHOULDER. THEY WERE ABLE TO GET THE DEVICE OUT OF THE SHOULDER WITHOUT ANY PATIENT HARM OR ANY PATIENT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15639716 ↗
• MalfunctionOct 6, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE JAW ON THE PENETRATING GRASPER 35° UP DEVICE WOULD NOT CLOSE WHILE PASSING THE SUTURE. 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 15552559 ↗
• MalfunctionJul 11, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN AUSTRALIA THAT DURING A REMPLISSAGE PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE HANDLE ON THE PENETRATING GRASPER 35° UP DEVICE BROKE. 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 14978548 ↗
• MalfunctionJun 1, 2022Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP IN FRANCE THAT PREOPERATIVELY TO AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE ARTHRO GRASPER PEN 35 UP DEVICE BROKE BEFORE USE. 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 14567106 ↗
• MalfunctionMay 4, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY THE AFFILIATE IN (B)(4) THAT THE TIP ON THE ARTHRO GRASPER PEN 35 UP DEVICE DID NOT OPEN. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14279190 ↗
• MalfunctionMar 17, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE JAWS OF THE UP BITING ON THE ARTHRO GRASPER PEN 35 UP DEVICE BROKE WHILE TRYING TO PASS SUTURE. 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 13792262 ↗
• MalfunctionDec 5, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE FORCEPS DID NOT CLOSE AND THE JAW WOULD NOT OPEN ON THE ARTHRO GRASPER PEN 35 UP DEVICE. 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 12931331 ↗
• MalfunctionAug 10, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE CUTTING EDGE ON THE ARTHRO GRASPER PEN 35 UP DEVICE DID NOT CLOSE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12303023 ↗
• MalfunctionMar 30, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE MOUTH OF THE PENETRATING GRASPER 35° UP WOULD NEITHER OPEN OR CLOSE. THERE WAS NO SURGICAL DELAY NOR ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11590660 ↗
• MalfunctionFeb 8, 2021Difficult 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) 2021, IT WAS OBSERVED THAT THE ARTHRO GRASPER PEN 35 UP *EA DEVICE WAS NOT WORKING CORRECTLY THAT THE JAW ON THE DEVICE WOULD NOT CLOSE ALL THE WAY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 30 SECOND TIME DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11295320 ↗
• MalfunctionDec 16, 2020Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE JAW ON THE PENETRATING GRASPER 35° UP DEVICE WAS NOT OPENING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11020157 ↗
• MalfunctionNov 9, 2020Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY SALES REP VIA COMPLAINT SUBMISSION TOOL AS FOLLOWS: CONTACT BY CSSD STAFF INFORMING ME THAT THE PENETRATING GRASPER 214601 FROM THEIR RCR EXTRAS CONSIGNMENT TRAY IS NOT OPENING OR CLOSING. UPON CLOSER INSPECTION, THE INSTRUMENT IS MISSING A SCREW. SEE ATTACHED PHOTO. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10810621 ↗
• MalfunctionOct 12, 2020Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER ARTHROSCOPY THE PENETRATING GRASPER 35° UP IS NOT CLOSING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10667775 ↗