NA 03.615.002Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034715223), received between Nov 15, 2017 and Feb 18, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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 18, 2026Mechanical Problem

  IT WAS REPORTED THE SMALL SCREWS THAT SECURE THE PIECE FOR RETRACTION OF THE BLADES KEEP LOOSENING AND ALLOWING THE PIECE FOR RETRACTION TO DETACH FROM THE RETRACTOR FRAME. NO PATIENT HARM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376797 ↗
• MalfunctionDec 10, 2025Use of Device Problem; Material Integrity Problem; Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING PRE-OPERATIVE TESTING IT WAS DISCOVERED THAT THE FLEX ARM WAS MISSING FIXING BOLTS, HAD BROKEN BEARING, AND THE FLEXIBLE HOSE TENSIONER WING NUT WAS NOT LOCKED. ALSO, THE RETRACTOR FRAME MEDIAL LATERAL WAS MISSING A FIXING BOLT AND ITS PRESSER FOOT HOLDER DID NOT HOLD POSITION. THE INSTRUMENTS WERE NOT USED DURING THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771779 ↗
• MalfunctionFeb 21, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2002, THE SURGEON WAS PERFORMING A L3-L5 MICRO DISC ON A PATIENT WITH THE SYNTHES INSIGHT BLADE RETRACTOR. THE SURGEON COULD NOT EXPAND OR TOE OUT EITHER OF THE RETRACTOR FRAMES, TRIED BOTH THE RETRACTOR FRAME MEDIAL/LATERAL AND RETRACTOR FRAME CRANIAL/CAUDAL. THE SURGEON ALSO DEMONSTRATED HOW ON 1 OF THE 2 ARMS THAT RATCHET THAT HOLDS THE ARM ARTICULATED MUST BE WORN OUT. THE ARM ON BOTH OF THESE RETRACTOR FRAMES WILL NOT HOLD. SURGICAL DELAY WAS ABOUT 4 MINUTES WHILE THE SURGEON ADJUSTED THE RETRACTOR TO MAKE IT WORK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO HARM TO THE PATIENT. THIS IS REPORT 01 OF 02 OF (B)(4).

  Patient problems: No Code Available

  MAUDE report 9741272 ↗
• MalfunctionSep 13, 2019Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2019 DURING SURGERY THE RETRACTOR FRAME MEDIAL LATERAL AND RETRACTOR FRAME CRANIAL CAUDAL DISTRACTORS OF THE MINIMALLY INVASIVE SURGICAL SUPPORT SYSTEM HAVE WORN OUT AND SLIPPING DURING SURGERY. THEY NO LONGER HOLD THE POSITION TIGHTLY THEY ARE INTENDED TO. SURGICAL DELAY IS UNKNOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY. PATIENT STATUS IS UNKNOWN. THIS IS REPORT 1 FOR 3 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9035306 ↗
• MalfunctionSep 13, 2019Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2019 DURING SURGERY THE RETRACTOR FRAME MEDIAL LATERAL AND RETRACTOR FRAME CRANIAL CAUDAL DISTRACTORS OF THE MINIMALLY INVASIVE SURGICAL SUPPORT SYSTEM HAVE WORN OUT AND SLIPPING DURING SURGERY. THEY NO LONGER HOLD THE POSITION TIGHTLY THEY ARE INTENDED TO. SURGICAL DELAY IS UNKNOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY. PATIENT STATUS IS UNKNOWN. THIS IS REPORT 3 FOR 3 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9035272 ↗
• MalfunctionNov 15, 2017Failure To Adhere Or Bond; Failure To Adhere Or Bond

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE FLEX ARMS ARE NOT HOLDING THE RETRACTOR FRAMES (CRANIAL CAUDAL AND MEDIAL LATERAL). IT IS IMPOSSIBLE TO PUSH THE FRAMES INTO THE HOLDING RING SLEEVE, SOMETHING IS BLOCKING INSIDE. THIS WAS DETECTED BEFORE THE SURGERY. NO PATIENT WAS INVOLVED. CONCOMITANT DEVICE REPORTED: HOLDING SLEEVE RING (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) RETRACTOR FRAME MEDIAL/LATERAL. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7033307 ↗