NA 214643Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886705004249), received between Jan 3, 2020 and Apr 11, 2024 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 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 SHARP TIP WAS OBSERVED TO BE BENT WHICH CAUSED AN OBSTRUCTION TO THE JAW, THEREFORE IT COULD NOT BE OPENED OR CLOSED.. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19087710 ↗
• MalfunctionApr 11, 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 SHARP TIP WAS NOTICEABLY BENT WHICH CAUSED AN OBSTRUCTION TO THE JAW, THEREFORE IT COULD NOT BE OPENED OR CLOSED.. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19087074 ↗
• MalfunctionJun 29, 2022Device-Device Incompatibility; Device-Device Incompatibility

  THIS IS REPORT 1 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 - LEFT 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 14856179 ↗
• MalfunctionMar 7, 2022Break; Difficult to Open or Close; Break; Difficult to Open or Close

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE ARTHRO SIXTER-LEFT DEVICE WAS NOT FUNCTIONING RELIABLY AS IT WOULD PENETRATE THE TISSUE BUT DID NOT OPEN. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE SAFETY SHEAR PIN WAS PARTIALLY BROKEN. 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 13685334 ↗
• MalfunctionMar 7, 2022Break; Difficult to Open or Close; Break; Difficult to Open or Close

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE ARTHRO SIXTER-LEFT DEVICE WAS NOT FUNCTIONING RELIABLY AS IT WOULD PENETRATE THE TISSUE BUT DID NOT OPEN. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE SAFETY SHEAR PIN WAS PARTIALLY BROKEN. 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 13685309 ↗
• MalfunctionSep 2, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE OF THE RIGHT SHOULDER ON (B)(6) 2021, IT WAS OBSERVED THAT THE ARTHRO SIXTER-LEFT 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 12415309 ↗
• MalfunctionJan 19, 2021Degraded; Degraded

  IT WAS REPORTED BY THE AFFILIATE IN AUSTRALIA THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE SIXTER DEVICE WAS BLUNT WHILE PASSING THROUGH THE LABRUM. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE SHAFT WAS BENT. THE SAME DEVICE WAS USED BUT WITH GREATER FORCE THAN USUAL TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11195569 ↗
• MalfunctionJan 3, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE CUSTOMER VIA PHONE THAT DURING AN ARTHROSCOPY PROCEDURE, IT WAS FOUND THAT THE TIP OF THEIR ARTHRO SIXER LEFT WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE TIP OF THE DEVICE WAS SLIGHTLY BENT. 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 9546027 ↗