NA 214603Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886705003860), received between Sep 18, 2018 and Dec 9, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2024Break; Break

  IT WAS REPORTED THAT PRIOR TO AN UNKNOWN PROCEDURE, THE ARTHRO GRASPER PEN 45 RIGHT DEVICE TIP OF THE JAWS HAD BROKEN OFF. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878895 ↗
• MalfunctionDec 29, 2022Difficult 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 DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE PENETRATING GRASPER 45° RIGHT DEVICE APPEARED WORN INDICATING DEVICE WAS HEAVILY USED, HAD SIGNS OF WEAR WITH THE LASER MARKINGS SLIGHTLY FADED. IT WAS FURTHER DETERMINED THAT THE JAW WAS LOOSE AND WAS NOT FUNCTIONING SMOOTHLY; AND WHEN THE TRIGGER OF THE DEVICE WAS PULLED, THE JAWS WOULD NOT ACTUATE OPEN/CLOSE CONSISTENTLY. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16069292 ↗
• MalfunctionSep 24, 2019Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT BEFORE AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE MITEK GRASPER WOULD NOT CLOSE ANYMORE. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. A SPARE DEVICE WAS AVAILABLE FOR USE TO COMPLETE THE SURGERY. 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9111050 ↗
• MalfunctionSep 13, 2019Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY THE SALES REP THAT DURING ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE PIN IN HANDLE ON THE ARTHRO GRASPER PEN 45 RIGHT *EA WAS MISSING. ACCORDING TO THE REPORTER, THE DEVICE WOULD NOT OPEN AND CLOSE. IT WAS FURTHER REPORTED THAT THE SURGEON COULD NOT PASS SUTURE WITH PRODUCT AND USED EXPRESSEW INSTEAD. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF 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 9036990 ↗
• MalfunctionMar 5, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT IN RELATION TO A ROTATOR CUFF REPAIR PROCEDURE THE PENETRATING GRASPER 35 DEGREES UP AND THE PENETRATING GRASPER 45 DEGREES RIGHT WERE BROKEN. THE SALES REP DID NOT KNOW HOW THE DEVICES BROKE OR WHERE ON EACH DEVICE IT WAS BROKEN. THE CASE WAS COMPLETED WITH A COMPETITOR'S DEVICE WITH NO PATIENT HARM OR DELAY. THE SALES REP WAS NOT PRESENT AND COULD NOT PROVIDE ANY ADDITIONAL INFORMATION. THE DEVICES WERE DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8392037 ↗
• MalfunctionSep 18, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE ARTHRO GRASPER PEN DEVICE WAS BROKEN. ACCORDING TO THE REPORTER, THE DEVICE WOULD NOT CLOSE PROPERLY. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. 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 7885388 ↗