NA 214575Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886705003822), received between Jul 25, 2018 and Apr 1, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT THE HANDLE OF THE ARTHRO SUTURE GRASPER WAS LOCKED, THE TIP OF THE SUTURE WAS TURNED SIDEWAYS, AND THE HANDLE AND PARTS OF THE SHAFT HAD COME OFF. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24752557 ↗
• MalfunctionAug 9, 2023Use of Device Problem; Difficult to Open or Close; Use of Device Problem; Difficult to Open or Close

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN FRANCE THAT THE 3.5MM SUTURE GRASPER DEVICE WAS NON-FUNCTIONAL. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE JAW COULD NOT BE OPENED OR CLOSED; AND THAT IT WAS FOUND LOOSE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17492160 ↗
• MalfunctionAug 16, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT THE 3.5MM SUTURE GRASPER WAS TOO HARD TO OPEN OR CLOSE AND COULD NOT BE USED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15235127 ↗
• MalfunctionMar 8, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT THE ARTHRO SUTURE GRASPER 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 13695350 ↗
• MalfunctionDec 9, 2020Break; Break

  IT WAS REPORTED FROM THE AFFILIATE IN (B)(6) THAT THE ARTHRO SUTURE GRASPER DEVICE BROKEN AFTER A PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10979039 ↗
• MalfunctionMar 26, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE THAT THE DEVICE BROKE. IT WAS NOTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8452750 ↗
• MalfunctionJan 18, 2019Break; Break

  IT WAS REPORTED THAT DURING A DEMONSTRATION IN A CADAVER LAB, IT WAS OBSERVED THAT THE ARTHRO SUTURE GRASPER *EA BROKE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF 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 8260218 ↗
• MalfunctionAug 6, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT PRIOR TO AN ACL PROCEDURE THE JAW ON THEIR SUTURE GRASPER IS BROKEN AND THEIR FEMORAL AIMER 8 MM OFFSET IS BENT. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE DEVICES. THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7753722 ↗
• MalfunctionJul 25, 2018Break; Break

  IT WAS REPORTED DAMAGED DEVICE. THE HANDLE AND THE SHAFT ARE BROKEN. NO CONSEQUENCES TO THE PATIENT - ANOTHER LIKE DEVICE WAS USED. THE FOLLOWING INFORMATION WAS RECEIVED FROM OUR AFFILIATE ON 8-5-14; THERE WAS NOTHING THAT BROKE OFF OF THE DEVICE AND FELL INTO THE PATIENT, AND THERE IS NO INFORMATION AS TO HOW OLD THE DEVICE IS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7721435 ↗