NA 214626Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886705004089), received between Mar 29, 2017 and Feb 5, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Device Damaged Prior to Receipt by User; Material Deformation

  IT WAS REPORTED THAT AFTER PREPARING THE NEW ANCILLARY TOOLS FOR THE ROTATOR CUFFS, AND WHEN OPENING THE PACKAGING OF THE ARTHRO SUTURE MANIP DEVICE IT WAS OBSERVED THAT THE DEVICE WAS BENT IN THE PACKAGING. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE TIP OF THE DEVICE WAS DEFORMED. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. 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 24272832 ↗
• MalfunctionMay 20, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT THE ARTHRO SUTURE DEVICE SUTURE MANIPULATOR JAWS KEPT OPENING WHEN TRYING TO PULL THE SUTURE FROM THE JOINT AND THE JAWS MAY HAVE BEEN LOOSE. 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 19351641 ↗
• MalfunctionNov 21, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT THE MANIPULATOR GRASPER DEVICE WAS MISALIGNED 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 18184694 ↗
• MalfunctionMay 24, 2023Break; Break

  THIS IS REPORT 3 OF 5 FOR (B)(4). IT WAS REPORTED THROUGH IN-HOUSE DISTRIBUTION THAT WHILE ORGANIZING THE SHELVES, IT WAS OBSERVED THAT THE SUTURE MANIPULATOR 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 16994559 ↗
• MalfunctionMay 1, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE SHAFT ON THE SUTURE MANIPULATOR GRASPER DEVICE WAS BENT. 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 16843540 ↗
• MalfunctionSep 29, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING INSPECTION PREOPERATIVELY ON (B)(6) 2022, IT WAS OBSERVED THAT DEFORMATION WAS FOUND ON THE SUTURE MANIPULATOR GRASPER DEVICE. ACCORDING TO THE REPORT, THE TIP OF THE UPPER PART/JAW ON THE DEVICE WAS DEFORMED, AND THE UPPER JAW AND THE LOWER JAW DID NOT ENGAGE PROPERLY. IT WAS FURTHER REPORTED THAT IT SEEMED TO BE DIFFICULT TO BE USED FOR PINCHING SUTURES OR TISSUES. 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 15505156 ↗
• MalfunctionMar 29, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT PREOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE SUTURE/ NEEDLE PASSER DEVICE WAS BENT. THERE WAS NO SURGICAL DELAY OR ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11582903 ↗
• MalfunctionMar 10, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP IN AUSTRALIA THAT DURING KIT INSPECTION, IT WAS OBSERVED THAT THE TIP ON THE ARTHRO SUTURE DEVICE WAS NOT ALIGNING IN CLOSED POSITION. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11455325 ↗
• MalfunctionDec 26, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER REPAIR PROCEDURE, IT WAS FOUND THAT THE MIDDLE OF THE METAL SHAFTS OF THE CUSTOMER'S KNOT PUSHER ARTHROSCOPIC AND SUTURE MANIPULATOR GRASPER WERE SLIGHTLY BENT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE DEVICES WITH NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THE SALES REP WAS NOT PRESENT FOR THE CASE; THEREFORE, COULD NOT PROVIDE ANY FURTHER INFORMATION OR LOT NUMBERS FOR THE DEVICES BUT STATED THAT BOTH DEVICES WERE APPROXIMATELY TWO YEARS AND HAVE SEEN HEAVY USE IN THE FIELD. THE DEVICES WERE DISCARDED BY THE CUSTOMER. 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 9519820 ↗
• MalfunctionDec 17, 2019Break; Loose or Intermittent Connection; Break; Loose or Intermittent Connection

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE SPRING FOR THIS SUTURE MANIPULATOR GRASPER WAS BROKEN. ACCORDING TO THE REPORT, IT HAD NO TENSION WHILE PICKING THE SUTURE THAT THE SPRING WAS BROKEN NOT ALLOWING THE JAW TO OPEN AND CLOSE PROPERLY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 9481613 ↗
• MalfunctionSep 13, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING SHOULDER REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE LOOP END ON THE ARTHRO SUTURE MANIP *EA DEVICE DID NOT SEEM TO CLOSE WHEN HANDLE WAS SQUEEZED. IT WAS REPORTED THAT THE SPRING WAS BELIEVED TO BE BROKEN OFF AS THE DEVICE IS 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 9035999 ↗
• MalfunctionSep 6, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF PROCEDURE WHEN THE SURGICAL TECH WAS OPERATING THE CUSTOMER'S SUTURE MANIPULATOR, IT WAS OBSERVED THAT THE TOP JAW BROKE OFF WHEN CLOSING THE JAWS. THE SALES REP STATED THAT THE DEVICE FAILURE OCCURRED OUTSIDE THE PATIENT. THE SALES REP REPORTED THAT 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 DEVICE BUT STATED THAT THE DEVICE IS APPROXIMATELY SIX YEARS OLD AND HAS SEEN HEAVY USE IN THE FIELD. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. THE SALES REP STATED THAT THE DEVICE WAS DISCARDED BY THE FACILITY. 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 7850288 ↗
• MalfunctionAug 29, 2018Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT DURING A SHOULDER ARTHROSCOPY, THE SUTURE BLOCKED ON THE DEVICE. THE SUTURE WAS REMOVED AND THE SURGEON REPLACED IT AGAIN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7831297 ↗
• InjuryMar 29, 2017Difficult to Open or Close; Difficult to Open or Close

  AFFILIATE REPORTED VIA EMAIL DURING ARTHROSCOPIC ROTATOR CUFF REPAIR, SUTURE ANCHOR BECAME DISLODGED (FROM OSTEOPENIC BONE). DURING ATTEMPTS BY SURGEON TO REMOVE THE LOOSE ANCHOR (ARTHROSCOPICALLY), BOTH DEVICES, MENTIONED ABOVE, WERE DAMAGED AND FAILED TO OPEN / CLOSE EFFECTIVELY. NEED REPLACING. ALTERNATE DEVICE (FROM COMPETITOR TRAY OF SHOULDER INSTRUMENTS) WERE USED TO EVENTUALLY REMOVE ANCHOR. TWO MINUTES DELAY. NO ADVERSE EVENT TO PATIENT. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON (B)(6) 2017 . THE ORIGINAL BONE HOLE WAS NOT USED TO COMPLETE THE PROCEDURE. THE BONE HOLE LEFT UNFILLED. SURGEON HAPPY WITH REPAIR WITH OTHER ANCHORS USED. LOT NUMBERS ARE AS FOLLOWS: RATCHETED GRASPER - (214606) - 16J02. SUTURE MANIPULATOR - (214626) - 13E01. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON 3-20-2017 NO PRODUCT INFORMATION HAD BEEN PROVIDED IN RELATION TO THE ANCHOR.

  Patient problems: Tissue Damage

  MAUDE report 6445066 ↗