NA 03.615.100Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705034715360), received between Nov 15, 2017 and Feb 18, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 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 24376704 ↗
• MalfunctionSep 2, 2025Mechanical Problem; Compatibility Problem; Mechanical Problem; Compatibility Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A & P LUMBAR FUSION ON (B)(6) 2025. THE RETRACTOR FRAME GOT STUCK REPEATED TIMES DURING RETRACTION AND THE BLADES WOULD NOT ANGULATE WHILE USING THE HANDLES. THE BLADES WERE USED WITHOUT THE PROPER RETRACTION. NO FRAGMENTS WERE GENERATED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22938327 ↗
• MalfunctionOct 6, 2023Compatibility Problem; Compatibility Problem

  EVENT OCCURRED INTRAOPERATIVELY ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17890033 ↗
• MalfunctionSep 26, 2023Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE MIS CRANIAL/CAUDAL DISTRACTOR IN QUESTION WAS NOT HOLDING PROPERLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCES. NO FRAGMENTS WERE GENERATED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A RETRACTOR FRAME CRANIAL/CAUDAL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17818365 ↗
• MalfunctionFeb 26, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION OF CONSIGNMENT SETS ON (B)(6) 2020, THE INSIGHT OF A RETRACTOR FRAME WOULD NOT HOLD THE ARTICULATION WITH THE ARM IS TOED OUT AND THE TEETH MUST BE WORN OUT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9758936 ↗
• 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 02 OF 02 OF (B)(4).

  Patient problems: No Code Available

  MAUDE report 9741269 ↗
• 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 2 FOR 3 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9035285 ↗
• MalfunctionAug 17, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE RETRACTOR FRAME CRANIAL/CAUDAL IS NOT HOLDING. IT IS UNKNOWN WHEN AND HOW THE MALFUNCTION WAS DISCOVERED. IT IS UNKNOWN IF THERE WAS PATIENT AND PROCEDURAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) RETRACTOR FRAME CRANIAL/CAUDAL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 7794764 ↗
• MalfunctionMay 10, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT ONE (1) RETRACTOR FRAME CRANIAL/CAUDAL FROM A SYNTHES FRAMES AND HANDLES CADDY DOES NOT HOLD POSITION AND IT SLOWLY SLIPS/ GIVES OVER TIME. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 7504919 ↗
• MalfunctionNov 28, 2017Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT A RETRACTOR FRAME CRANIAL/CAUDAL IS NOT HOLDING THE RETRACTOR. THE DEVICE WILL NOT STAY OPEN. THE LOCKING MECHANISM WILL NOT HOLD AND THE GEAR INSIDE THE DEVICE MAY BE STRIPPED. THIS WAS DISCOVERED IN CENTRAL STERILE PROCESSING. THERE IS NO PATIENT OR PROCEDURE INVOLVEMENT. CONCOMITANT DEVICES REPORTED: RETRACTOR (PART NUMBER UNKNOWN, LOT NUMBER: UNKNOWN, QTY. 1) THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7062979 ↗
• MalfunctionNov 27, 2017Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT A RETRACTOR FRAME CRANIAL/CAUDAL IS NOT HOLDING THE RETRACTOR. THE DEVICE WILL NOT STAY OPEN. THE LOCKING MECHANISM WILL NOT HOLD AND THE GEAR INSIDE THE DEVICE MAY BE STRIPPED. THIS WAS DISCOVERED IN CENTRAL STERILE PROCESSING. THERE IS NO PATIENT OR PROCEDURE INVOLVEMENT. CONCOMITANT DEVICES REPORTED: RETRACTOR (PART NUMBER UNKNOWN, LOT NUMBER: UNKNOWN, QTY. 1). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7062068 ↗
• MalfunctionNov 15, 2017Failure To Adhere Or Bond; Failure To Adhere Or Bond

  DEVICE REPORT FROM SYNTHES EUROPE 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 CRANIAL/CAUDAL. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7033308 ↗