NA 03.816.002Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034730639), received between Jan 9, 2017 and Sep 30, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Compatibility Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951546 ↗
• MalfunctionMar 3, 2025Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT THE BLADE HOLDER CANNOT BE INSERTED INTO THE RETRACTOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21504505 ↗
• MalfunctionSep 1, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE DEMO ON AN UNKNOWN DATE, THE BLADE HOLDER WAS NOT ENGAGING WITH THE BLADE AND SALES REP WAS UNABLE TO ACTUALLY PUT TOGETHER THE RETRACTOR. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) BLADE HOLDER-LEFT. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10480283 ↗
• MalfunctionJan 9, 2017Break; Break

  IT WAS INITIALLY REPORTED ON (B)(6) 2016 THAT DURING THE SYNTHES SERVICE AND REPAIR EVALUATION OF THE BLADE HOLDER, IT WAS DISCOVERED THAT THE INSTRUMENT WAS DAMAGED ON THE SIDE. THERE WERE NO ALLEGATION OF COMPLAINT BY THE CUSTOMER, NOR WAS THERE REPORTED PATIENT INVOLVEMENT. DURING INVESTIGATION OF THE RETURNED DEVICE BY SYNTHES CUSTOMER QUALITY ENGINEERING ON (B)(6) 2017, IT WAS DISCOVERED THAT A PORTION OF THE DEVICE HAD BROKEN OFF AND WAS MISSING. THE COMPLAINT EVENT WAS RE-EVALUATED AND DETERMINED TO BE REPORTABLE BASED ON THIS ADDITIONAL INFORMATION. THIS REPORT IS 1 OF 1 FOR COM-(B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6233731 ↗