NA 214642Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886705004232), received between Sep 25, 2019 and Apr 10, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2024Material Deformation; Appropriate Device Problem Term/Code Not Available; Material Deformation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE AFFILIATE IN IRELAND THAT DURING SERVICE AND REPAIR, IT WAS DETERMINED THAT ARTHRO SIXTER-RIGHT *EA DEVICE WAS DEFECTIVE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DISTAL PART OF THE JAW IS BENT. THE DEICE DID NOT OPEN AND CLOSE DUE TO THE JAW CONDITION. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19083431 ↗
• MalfunctionApr 10, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE AFFILIATE IN IRELAND THAT DURING SERVICE AND REPAIR, IT WAS DETERMINED THAT ARTHRO SIXTER-RIGHT *EA DEVICE WAS DEFECTIVE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE SHARP TIP WAS DEFORMED. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19083264 ↗
• MalfunctionApr 10, 2024Material Deformation; Appropriate Device Problem Term/Code Not Available; Material Deformation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE AFFILIATE IN IRELAND THAT DURING SERVICE AND REPAIR, IT WAS DETERMINED THAT ARTHRO SIXTER-RIGHT *EA DEVICE WAS DEFECTIVE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE SHARP TIP WAS DEFORMED. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19082808 ↗
• MalfunctionOct 5, 2022Material Deformation; Material Deformation

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY A FIELD SERVICE ENGINEER IN AUSTRALIA THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE SIXTER - RIGHT 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 15545263 ↗
• MalfunctionJun 29, 2022Device-Device Incompatibility; Device-Device Incompatibility

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE SIXTER - RIGHT DEVICE WAS ABLE TO CAPTURE THE SUTURE INITIALLY BUT WHEN THE SUTURE WAS PASSED THROUGH THE TISSUE, IT WAS LOST. 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 14856321 ↗
• MalfunctionJun 14, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY THE AFFILIATE IN GERMANY THAT POSTOPERATIVELY TO AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE ARTHRO SIXTER-RIGHT DEVICE DID NOT CLOSE AND WOULD OPEN POORLY AFTER EACH USE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE SHAFT ON THE DEVICE WAS BENT AND THE JAW AT THE DISTAL TIP DID NOT FUNCTION AS IT WAS LOOSE. 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 11991110 ↗
• MalfunctionSep 25, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR, IT WAS OBSERVED THAT THERE WAS A SNAP SOUND THAT WAS HEARD WHEN THE SURGEON WAS PUSHING THE ARTHRO SIXTER-RIGHT *EA DEVICE INTO THE INCISION. ACCORDING TO THE REPORT, THE EVENT OCCURRED WHEN THE SURGEON PICKED UP THE DEVICE AND ATTEMPTED TO USE IT ON THE PATIENT BUT DUE TO THE SWELLING OF THE PATIENT IT WAS DIFFICULT TO GET THE DEVICE IN THE INCISION. IT WAS FURTHER REPORTED THAT WHEN THE SURGEON PULLED THE SIXTER OUT, HE REALIZED THAT HE MUST HAVE BROKEN THE MECHANISM THAT OPENS AND CLOSES THE JAWS OF THE DEVICE. IT WAS REPORTED THAT ANOTHER TRAY WAS OPENED TO USE THE CLEVER HOOKS INSTEAD FOR THE REST OF THE CASE. THE SURGERY WAS DELAYED ONLY ABOUT ONE MINUTE WHILE WE GRABBED THE TRAY TO OPEN THE CLEVER HOOKS. THERE WAS A 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 9117649 ↗