NA 388.612Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705034773629), received between Oct 2, 2018 and Feb 18, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Material Integrity Problem

  IT WAS REPORTED WHEN PLACING THE HOOK INSTRUMENT (STICK) THE BOTTOM END OF THE INSTRUMENTS - THREADED PORTION THAT¿S WITHIN THE HOOK SHEARED OFF INSIDE THE HOOK - NO HARM WAS DONE TO THE PATIENT. THE HOOK IMPLANT WAS UNUSABLE SO ANOTHER HOOK HAD TO BE OPENED AND ANOTHER STICK USED. THERE WAS ONLY A MINUTE DELAY TO THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377371 ↗
• MalfunctionNov 7, 2024Use of Device Problem; Material Integrity Problem; Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE CUSTOMER RETURNED THE MODULE BECAUSE IT WAS BROKEN. THERE WAS NO IMPACT ON SURGERY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20629211 ↗
• MalfunctionSep 25, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 A PATIENT UNDERWENT THE REVISION OF USSII SCOLIOSIS FOR PEDICLE SCREW, WHICH WAS IMPLANTED MORE THAN 10 YEARS AGO. DURING THE REVISION PROCEDURE AN INSTRUMENT HANDLE SNAPPED. METAL PINS HOLDING THE METAL KNOB IN PLACE SNAPPED. INSTRUMENT BROKE INTO 11 PIECES. SIGNIFICANT BONE GROWTH AROUND THE SCREW BEING REVISED MADE IT DIFFICULT TO EXTRACT AND EXTRA FORCE EXERTED TO EXTRACT THE SCREW. SURGEON USED THE SECOND SCREW HOLDER ON THE SET SO THERE WAS NO DELAY IN SURGERY. NO FRAGMENTS FELL INTO THE WOUND, VISUAL CHECKS COMPLETED AND NO ADVERSE OUTCOME TO THE PATIENT. THIS REPORT IS FOR ONE (1) HOOK/SCREW HOLDER WITH 4.0MM HEX. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17812354 ↗
• MalfunctionMay 23, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN UNITED KINGDOM THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT TWO SCREWDRIVER DEVICES WERE BENT. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14469474 ↗
• MalfunctionJun 29, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, ROD HOLDER WAS NOT WORKING PROPERLY. THE SCREW EXTENSIONS TIPS WERE BENT AND AREN'T SCREWING IN PROPERLY. I HAVEN'T INSPECTED IT MYSELF TO DETERMINE THE ACTUAL ISSUE BUT WILL PICK IT UP AND SEND IT IN SHORTLY. THIS REPORT IS FOR ONE (1) HOOK/SCREW HOLDER WITH 4.0MM HEX. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12086723 ↗
• MalfunctionJun 29, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, ROD HOLDER WAS NOT WORKING PROPERLY. THE SCREW EXTENSIONS TIPS WERE BENT AND AREN'T SCREWING IN PROPERLY. I HAVEN'T INSPECTED IT MYSELF TO DETERMINE THE ACTUAL ISSUE BUT WILL PICK IT UP AND SEND IT IN SHORTLY. THIS REPORT IS FOR ONE (1) HOOK/SCREW HOLDER WITH 4.0MM HEX. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12086715 ↗
• MalfunctionMay 4, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM THE (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE SURGICAL TEAM USED A STALK TO FINAL TIGHTEN A SCREW AND FELT LIKE IT WAS ABOUT TO SNAP. ANOTHER STALK WAS USED INSTEAD FOR THE REMAINING SCREWS. THE ITEM HAS SINCE BEEN DISCARDED. THERE WAS NO PATIENT IMPACT OR DELAY TO SURGERY. THIS REPORT IS FOR A HOOK/SCREW HOLDER WITH 4.0MM HEX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769623 ↗
• MalfunctionJun 19, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HOOK/SCREW HOLDERS AND HEXAGONAL SCREWDRIVER WERE BROKEN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) HOOK/SCREW HOLDER WITH 4.0 MM HEX. THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8712802 ↗
• MalfunctionJun 19, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HOOK/SCREW HOLDERS AND HEXAGONAL SCREWDRIVER WERE BROKEN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) HOOK/SCREW HOLDER WITH 4.0 MM HEX. THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8712794 ↗
• MalfunctionJun 19, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HOOK/SCREW HOLDERS AND HEXAGONAL SCREWDRIVER WERE BROKEN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) HOOK/SCREW HOLDER WITH 4.0MM HEX. THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8712773 ↗
• MalfunctionJun 19, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HOOK/SCREW HOLDERS AND HEXAGONAL SCREWDRIVER WERE BROKEN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) HOOK/SCREW HOLDER WITH 4.0MM HEX. THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8712762 ↗
• MalfunctionJun 19, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HOOK/SCREW HOLDER AND HEXAGONAL SCREWDRIVER WERE BROKEN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) HOOK/SCREW HOLDER WITH 4.0 MM HEX. THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8712371 ↗
• MalfunctionOct 2, 2018Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING SPINAL FUSION SURGERY, THE TIP OF (4) UNIVERSAL SPINAL SYSTEM (USS) HOOK AND SCREW HOLDERS GOT BENT DURING SCREW MANIPULATION. THEY SCREW ON TO THE SCREW HEADS AND THE SURGEON MANIPULATED THEM FOR ROD AND CAP INSERTION. AS THEY WERE BEING HANDLED, THE SURGEON NOTICED THAT SOME WERE BENDING. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) HOOK/SCREW HOLDER WITH 4.0MMHEX DEVICES. THIS REPORT IS 4 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7928337 ↗
• MalfunctionOct 2, 2018Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING SPINAL FUSION SURGERY, THE TIP OF (4) UNIVERSAL SPINAL SYSTEM (USS) HOOK AND SCREW HOLDERS GOT BENT DURING SCREW MANIPULATION. THEY SCREW ON TO THE SCREW HEADS AND THE SURGEON MANIPULATED THEM FOR ROD AND CAP INSERTION. AS THEY WERE BEING HANDLED, THE SURGEON NOTICED THAT SOME WERE BENDING. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) HOOK/SCREW HOLDER WITH 4.0MM HEX DEVICES. THIS REPORT IS 3 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7928333 ↗