NA 388.50Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10705034773292), received between Apr 27, 2018 and Oct 28, 2025 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2025Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT USS COLLAR IMPLANT WAS NOT ATTACHING TO THE PERSUADER DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23401433 ↗
• MalfunctionSep 17, 2025Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT BOTH PERSUADERS HAD ISSUES DURING SURGERY. ONE CANNOT HAVE THE USS COLLARS LOCK TO IT AND THE OTHER ONE IS LOOSE WHERE IT CONNECTS WITH THE USS COLLARS, AND THE SCREW IS STRIPPED TO TIGHTEN IT. SURGERY WAS NOT DELAYED DUE TO THE EVENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23076375 ↗
• MalfunctionAug 21, 2025Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT BOTH PERSUADERS HAD ISSUES DURING SURGERY. ONE CANNOT HAVE THE USS COLLARS LOCK TO IT AND THE OTHER ONE IS LOOSE WHERE IT CONNECTS WITH THE USS COLLARS, AND THE SCREW IS STRIPPED TO TIGHTEN IT. SURGERY WAS NOT DELAYED DUE TO THE EVENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22861978 ↗
• MalfunctionAug 20, 2025Mechanical Problem; Compatibility Problem; Material Integrity Problem; Mechanical Problem; Compatibility Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PERSUADER TUBE, WHERE THE COLLAR CONNECTS, IS LOOSE AND THE SCREW TO TIGHTEN IT IS STRIPPED. ALSO, THE USS SCREW HOLDER IS STRIPPED AND WILL NOT CONNECT TO SCREWS. THERE WAS NO SURGICAL DELAY. THE PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22850352 ↗
• MalfunctionDec 15, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT PERSUADER BROKE DURING SURGERY. THE ADDITIONAL INSTRUMENTS IN THE SET WERE UTILIZED. THERE WAS NO OTHER MEDICAL INTERVENTION REQUIRED. THERE WERE NO FRAGMENTS GENERATED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED, THIS COMPLAINT INVOLVES ONE DEVICE. THIS REPORT IS FOR ONE ROD INTRODUCTN PLIERS F/ SIDE-OPEN IMPS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15984262 ↗
• MalfunctionFeb 4, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A SPINAL FUSION PROCEDURE. TWO USS PERSUADERS WERE UNABLE TO BE USED FOR THE PROCEDURE DUE TO MECHANICAL ISSUES. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13450549 ↗
• MalfunctionFeb 4, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A SPINAL FUSION PROCEDURE. TWO USS PERSUADERS WERE UNABLE TO BE USED FOR THE PROCEDURE DUE TO MECHANICAL ISSUES. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13450544 ↗
• MalfunctionDec 17, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE BROKEN ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS RECEIVED FOR REPAIR. NO FURTHER INFORMATION RECEIVED. THIS REPORT IS FOR ONE (1) ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13026057 ↗
• MalfunctionNov 19, 2020Break; Break

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION, IT WAS FOUND OUT THAT A ROD INTRODUCTION PLIERS (PERSUADER) HAD A BROKEN TUBE. THE TUBE WAS BROKEN AT THE TIP OF THE TUBE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10869341 ↗
• MalfunctionNov 19, 2020Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A SCOLIOSIS T10-L5 FUSION PROCEDURE. UPON INSPECTION, DURING SETUP, IT WAS NOTICED THAT THE HANDLES OF TWO (2) SOCKET WRENCH WITH STRAIGHT HANDLE (WITH SILICONE HANDLE) HAD A RESIDUE OF WHITE POWDER IN THE CANNULA RESULTING IN THE ENTIRE STERILE FIELD BEING CONTAMINATED. DURING THE SURGERY, TWO (2) ROD INTRODUCTION PLIERS WERE USED AND ENDED UP GETTING STUCK INSIDE A HOOK/SCREW HOLDER AND THE HANDLE OF A SOCKET WRENCH WITH STRAIGHT HANDLE DISINTEGRATED UPON ROUTINE TIGHTENING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THIRTY (30) MINUTE SURGICAL DELAY. THE PATIENT'S STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN NUT (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1) THIS REPORT IS FOR ONE (1) ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10868354 ↗
• MalfunctionNov 19, 2020Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A SCOLIOSIS T10-L5 FUSION PROCEDURE. UPON INSPECTION, DURING SETUP, IT WAS NOTICED THAT THE HANDLES OF TWO (2) SOCKET WRENCH WITH STRAIGHT HANDLE (WITH SILICONE HANDLE) HAD A RESIDUE OF WHITE POWDER IN THE CANNULA RESULTING IN THE ENTIRE STERILE FIELD BEING CONTAMINATED. DURING THE SURGERY, TWO (2) ROD INTRODUCTION PLIERS WERE USED AND ENDED UP GETTING STUCK INSIDE A HOOK/SCREW HOLDER AND THE HANDLE OF A SOCKET WRENCH WITH STRAIGHT HANDLE DISINTEGRATED UPON ROUTINE TIGHTENING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THIRTY (30) MINUTE SURGICAL DELAY. THE PATIENT'S STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN NUT (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10868282 ↗
• MalfunctionMay 26, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020 DURING A ROUTINE INSPECTION OF CONSIGNMENT INSTRUMENT SETS AT THE HOSPITAL, THE FOLLOWING ITEMS WERE FOUND TO BE IN NEED OF REPAIR OR REPLACEMENTS. THE ROD INTRODUCTION PLIERS FOR SIDE OPENING IMPLANTS DOES NOT HOLD THE COLLAR IMPLANT AND THE PRONGS THAT HOLD IT MUST BE SPLAYED. THE SOCKET WRENCH WITH STRAIGHT HANDLE 11MM WIDTH ACROSS FLATS DOES NOT HOLD THE COLLAR, THE COLLAR DROPS OUT AND DOES NOT SELF-RETAIN. THERE IS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE: UNK - MONO/POLYAXIAL SCREW COLLARS/SLEEVES/HEADS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS REPORT IS FOR 1 ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10088165 ↗
• MalfunctionOct 23, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2019 PRIOR TO START A POSTERIOR SPINAL FUSION PROCEDURE, THE SCRUB TECHNICIAN COULD NOT PLACE A UNIVERSAL SPINAL SYSTEM (USS) TITANIUM (TI) COLLAR ONTO THE USS ROD INTRODUCTION PLIERS. AFTER LOOKING AT THE TUBE ON THE USS ROD INTRODUCTION PLIERS, IT WAS DISCOVERED THAT THE TUBE WAS BENT (OBLONG). ANOTHER INSTRUMENT WAS AVAILABLE FOR USE PRIOR TO THE SURGERY THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: USS TI COLLAR ( PART# 498.010, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

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

  MAUDE report 9227004 ↗
• MalfunctionOct 14, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A T10-ILIUM POSTERIOR SPINAL FUSION WITH SYNTHES SPINE USS, THE TUBE OF THE ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANT BROKE WHEN PUTTING IN THE RODS. THE FRAGMENT FROM THE TUBE WAS RETRIEVED AND DISCARDED. THEY WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. ANOTHER PERSUADER WAS ALREADY AVAILABLE SO THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO HARM TO THE PATIENT. CONCOMITANT DEVICE REPORTED: UNKNOWN RODS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9188753 ↗
• MalfunctionJun 14, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TWO (2) ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS WERE BROKEN. IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED. IT IS UNKNOWN IF THERE WAS A PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8701607 ↗
• MalfunctionJun 14, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TWO (2) ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS WERE BROKEN. IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED. IT IS UNKNOWN IF THERE WAS A PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8701574 ↗
• MalfunctionOct 26, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION OF INSTRUMENTS ON (B)(6) 2018, IT WAS NOTED THAT IT WAS NOTED THAT THE FOLLOWING INSTRUMENTS WERE FOUND TO HAVE DEVICE ISSUES. ON THE FIRST ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS, ITS SET SCREW IN THE PART THAT SLIDES UP AND DOWN THE TUBE IS NOT LONG ENOUGH TO KEEP IT IN THE TRACK. ON THE SECOND ROD INTRODUCTION PLIERS, ITS RATCHET DOES NOT HOLD DURING LOADING ACCORDING TO A NOTE ON THE DEVICE, AND THE PLIERS MIGHT BE BENT. THERE WERE NO PROCEDURE AND PATIENT INVOLVEMENT. THIS REPORT IS FOR A ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8008859 ↗
• MalfunctionOct 15, 2018Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A ROD INTRODUCTION PLIER FOR SIDE-OPENING IMPLANT TUBE WAS ROTATED AND THE SLEEVE (HOLDS THE COLLAR IMPLANT) THAT SLIDES UP AND DOWN THE "TUBE" GOT JAMMED ON THE TUBE DURING A ROUTINE INSPECTION OF CONSIGNMENT INSTRUMENT SETS. THE SET SCREW THAT KEEPS THE SLEEVE IN AN OPEN TRACK ON THE TUBE WAS TOO SHORT AND DOES NOT GO INTO THE TRACK FAR ENOUGH. THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7967044 ↗
• MalfunctionOct 9, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION ON (B)(6) 2018, THE ISSUE TABS ON A ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS WERE FOUND TO BE SPLAYED. THE SLEEVE IS ALSO STUCK ON THE TUBE AND WILL NOT MOVE. IT WAS ALSO NOTED THAT THE RATCHET ON ANOTHER ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS FALLS OFF AND WILL NOT STAY ON THE INSTRUMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7950145 ↗
• MalfunctionOct 9, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION ON (B)(6) 2018, THE ISSUE TABS ON A ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS WERE FOUND TO BE SPLAYED. THE SLEEVE IS ALSO STUCK ON THE TUBE AND WILL NOT MOVE. IT WAS ALSO NOTED THAT THE RATCHET ON ANOTHER ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS FALLS OFF AND WILL NOT STAY ON THE INSTRUMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7950124 ↗
• MalfunctionSep 24, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION OF INSTRUMENTS ON (B)(6) 2018, IT WAS NOTED THAT ON THE ROD INTRODUCTION PLIERS, ITS RATCHET DOES NOT HOLD DURING LOADING ACCORDING TO A NOTE ON THE DEVICE, AND THE PLIERS MIGHT BE BENT. THERE WERE NO PROCEDURE AND PATIENT INVOLVEMENT. THIS REPORT IS FOR A ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7903326 ↗
• MalfunctionMay 15, 2018Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING AN UNKNOWN SPINAL SURGERY ON (B)(6) 2018, IT WAS NOTED THE ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS WAS NOT HOLDING WHILE THE INSTRUMENT WAS DEPRESSED. THERE WAS ALSO A CRACK NOTED IN THE SPRING OF THE DEVICE. DURING THE SAME PROCEDURE IT WAS NOTED THAT THE ROD BENDER WITH BEND RADIUS ADJUSTMENT WAS MISSING THE SPRING, WHICH PREVENTED THE DEVICE FROM TIGHTENING. BOTH DEVICES WERE SET ASIDE AND OTHER SIMILAR DEVICES WERE READILY AVAILABLE AND WERE USED TO COMPLETE THE SURGERY SUCCESSFULLY WITH NO DELAY AND NO PATIENT HARM. THE SERVICE AND REPAIR EVALUATION REVEALED THE SPRING ON THE ROD INTRODUCTION PLIERS WAS BROKEN AND THE PLIERS WERE TOO TIGHT. THIS REPORT IS FOR ONE (1) ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7516703 ↗
• MalfunctionApr 27, 2018Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A ROD INTRODUCTION PLIERS, FOR SIDE-OPENING IMPLANTS WAS NOT FUNCTIONING PROPERLY. THE SET SCREW THAT SECURE THE CLIP ON THE TUBE WAS NOT WORKING CORRECTLY; IT WAS LOOSE AND OUT OF THE TRACK. THIS WAS IDENTIFIED DURING ROUTINE INSPECTION; THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7468034 ↗