NA 03.615.009Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034715278), received between Dec 22, 2017 and Aug 13, 2019 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2019Device-Device Incompatibility; Device-Device Incompatibility

  9/13/2019: UPDATED EVENT DESCRIPTION: THE PROCEDURE WAS COMPLETED WITH THE SAME PERSUADER. THE DEVICE STILL WORKED, HOWEVER, THE SURGEON WAS EXPERIENCING SOME CHALLENGES. NO PROBLEM WITH THE SCREW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8887748 ↗
• MalfunctionFeb 8, 2019Device Slipped; Material Twisted/Bent; Device Slipped; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION OF CONSIGNMENT INVENTORY INSTRUMENT SETS, IT WAS NOTICED THAT THE "FORKS" ON THE HANDLE OF A SYNAPSE PERSUADER THAT ENGAGE THE TUBE OF THE PERSUADER ARE BEGINNING TO SPLAY AND THE HANDLE IS LOOSE ON THE TUBE. NO PROCEDURE AND PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) PERSUADER FOR 4.0MM RODS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8321091 ↗
• MalfunctionFeb 15, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION OF CONSIGNMENT SETS (FIELD INVENTORY) THE FOLLOWING INSTRUMENTS WERE FOUND TO BE IN NEED OF REPAIR AND/OR REPLACEMENT: THE HANDLE FOR A PERSUADER FOR 4.0 MM RODS DOES NOT OPERATE PROPERLY MAKING IT VERY HARD TO SQUEEZE. THE RETENTION CLIP FOR A ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS IS SPLAYED AND DOES NOT HOLD THE COLLAR SECURELY. THE CONNECTOR OF THE FLEX ARM WILL NOT FIT INTO THE RETRACTOR. IT'S BELIEVED THERE IS SOMETHING WRONG WITH THE CONNECTION. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION AVAILABLE. THIS COMPLAINT IS FOR TWO (2) DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7275565 ↗
• InjuryDec 22, 2017Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2017, SURGERY FOR CERVICAL MYELOPATHY WAS PERFORMED USING THE SYNAPSE 4.0 SYSTEM. THE FIXED AREA WAS C1 ¿ T1. DURING THE SURGERY, ALL SCREWS WERE INSERTED AS PLANNED. TIGHTENING THE ROD ON THE LEFT SIDE WAS SUCCESSFULLY DONE USING THE ROD INTRODUCTIONING INSTRUMENT. HOWEVER, ON THE RIGHT SIDE THIS INSTRUMENT GOT STUCK IN THE SCREW HEAD AND COULD NOT BE REMOVED. THE SURGEON TRIED TO ROTATE THE DEVICE COUNTER-CLOCKWISE AND IMPACTED IT WITH A HAMMER. HE REMOVED THE ROD AND THEN INSERTED A SCREWDRIVER OVER THIS INSTRUMENT. AS A RESULT, HE COULD SUCCESSFULLY REMOVE THIS INSTRUMENT TOGETHER WITH THE SCREW. HE INSERTED A NEW SCREW OF THE SAME SIZE AT THE LOCATION WHERE THE FORMER SCREW WAS BEING INSERTED. AT THE TIME OF ADJUSTING THE DIRECTION OF SCREW HEAD, THE ALIGNMENT TOOL GOT STUCK IN THE SCREW HEADS. THIS EVENT HAPPENED A COUPLE OF TIMES DURING THE SURGERY. THE SURGEON MANAGED TO REMOVE THIS TOOL WHILE HOLDING THE SCREW HEADS WITH A PLIER. NO BROKEN PARTS WERE FOUND LEFT IN THE BODY, AND THE SURGERY WAS DELAYED DUE TO THESE EVENTS BY AN UNKNOWN NUMBER OF MINUTES. THERE WAS NO ADVE

  Patient problems: No Code Available

  MAUDE report 7143268 ↗