Arthrex® AR-600SAGMISRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867111103), received between Mar 5, 2024 and Feb 11, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionFeb 11, 2025Break; Break

  ON 01/28/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT TWO (QTY.2) AR-600SAGMIS SAGITTAL SAW ATTACHMENTS ARE FALLING APART AND UNABLE TO CONNECT BLADE ATTACHMENTS. THEY OCCURRED DURING USE IN A CASE. NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21353743 ↗
• MalfunctionFeb 11, 2025Break; Break

  ON 01/28/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT TWO (QTY.2) AR-600SAGMIS SAGITTAL SAW ATTACHMENTS ARE FALLING APART AND UNABLE TO CONNECT BLADE ATTACHMENTS. THEY OCCURRED DURING USE IN A CASE. NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21353717 ↗
• MalfunctionJan 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 12/11/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-600SAGMIS SAGITTAL SAW ATTACHMENT FELL APART DURING A CASE. NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21095277 ↗
• MalfunctionOct 14, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  ON 09/24/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06671072 THAT AN AR-600SAGMIS SAGITTAL SAW ATTACHMENT CAME APART DURING A CASE. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20439274 ↗
• MalfunctionMay 16, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED ON 10/20/2021 BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-600SAGMIS SAW ATTACHMENT DOES NOT GRAB THE BLADE AND THAT COMPLICATES THE CUT. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19331306 ↗
• MalfunctionMar 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SAW ATTACHMENT BECOMES LOOSE WHILE SAWING. DUE TO THAT ISSUE, THE SAW BLADE FALLS OUT OF THE ATTACHMENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THIS WAS NOTICED BEFORE THE SURGERY. NO FURTHER INFORMATION RECEIVED. UPDATE DW: 16-FEB-2024: FURTHER INFORMATION WERE PROVIDED THAT APPARENTLY THE EVENT OCCURRED DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18835638 ↗