NA 03.607.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705034712857), received between Feb 8, 2017 and Jan 7, 2025 — classified as 2 injuries, 10 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. 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIP ON BOTH SCREWDRIVERS BROKE OFF. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. FRAGMENT GENERATED AND WAS EASILY REMOVED WITHOUT REQUIRING ADDITIONAL INTERVENTION. PATIENT CONSEQUENCE WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21091223 ↗
• MalfunctionJan 7, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIP ON BOTH SCREWDRIVERS BROKE OFF. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. FRAGMENT GENERATED AND WAS EASILY REMOVED WITHOUT REQUIRING ADDITIONAL INTERVENTION. PATIENT CONSEQUENCE WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21091222 ↗
• MalfunctionJan 2, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED DURING THE PROCEDURE ON (B)(6) 2024, THE SCREWDRIVER TIP SNAPPED OFF WHEN THE SURGEON WAS TRYING TO REMOVE METAL WORK THAT HAD BEEN INSITU IN A PATIENT FOR A NUMBER OF YEARS. ANOTHER SCREWDRIVER WAS USED TO COMPLETE THE PROCEDURE WITH NO DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21054959 ↗
• MalfunctionMay 4, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A REMOVAL OF L4/5 GLOBUS SCREWS AND A POSTERIOR SPINAL FUSION AT L5/S1 AT BRISBANE PRIVATE HOSPITAL ON THE 7.04.2022. WHEN INSERTING THE THIRD SCREW (THE RIGHT S1 SCREW) THE SCREWDRIVER 03.607.001 WAS BENT AT THE DISTAL END. THERE WAS NO HARM DONE TO THE PATIENT AND A SECOND DRIVER THAT WAS ON THE SET WAS USED. THIS DRIVER WAS FROM THE CONSIGNED USS II POLY KIT ZXAUSP0534, SERIAL NO: (B)(4), EQUIPMENT NUMBER: 300007912 (?). THIS REPORT IS FOR ONE (1) USS-II POLYAX HOLD-SLEEVE F/03.607.001. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14272289 ↗
• MalfunctionMay 6, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PRIOR TO A PROCEDURE ON (B)(6), 2021, IT WAS DISCOVERED THAT A DEVICE IN THE LOAN SET WAS DAMAGED AND HAD BEEN DELIVERED AS SUCH. ANOTHER INSTRUMENT WAS USED FOR THE PROCEDURE. THIS REPORT IS FOR A 3.0MM BIHEXAGONAL SCREWDRIVER WITH T-HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787279 ↗
• MalfunctionFeb 28, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A SCREWDRIVER STRIPPED IN SITU. USED SAME LIKE PRODUCT TO COMPLETE THE PROCEDURE. A SPRING ALSO WAS BROKEN PRIOR TO USE, AND SAME LIKE PRODUCT WAS USED TO COMPLETE THE PROCEDURE, NO SIGNS, SYMPTOMS OR PATIENT INVOLVEMENT, PROCEDURE SUCCESSFULLY COMPLETED. THIS REPORT IF FOR ONE (1) 3.0MM BI HEXAGONAL SCREWDRIVER WITH T-HANDLE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 9770669 ↗
• MalfunctionOct 3, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIGHTENING END OF SCREWDRIVER SNAPPED OFF. THIS CASE WAS REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS REPORT IS FOR ONE (1) 3.0MM BIHEXAGONAL SCREWDRIVER WITH T-HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9151893 ↗
• MalfunctionAug 9, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A SPINAL FUSION FOR PELVIC FRACTURE ON (B)(6) 2019 A SCREWDRIVER BROKE. WHILE THE SURGEON WAS DRILLING THE ILIAC BONE WITH THE SCREWDRIVER, THE TORQUE BECAME EXCESSIVELY LARGER DUE TO THE HARD BONE QUALITY, AND THE SCREWDRIVER¿S TIP BROKE OFF. IT WAS CONFIRMED BY X-RAYS THAT NO FRAGMENT LEFT IN THE PATIENT'S BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH LESS THAN 30-MINUTE SURGICAL DELAY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8879524 ↗
• InjuryJan 10, 2019Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, A PATIENT UNDERWENT AN UNKNOWN SURGERY FOR PELVIC TORSO FRACTURE. THE SURGEON ATTEMPTED TO IMPLANT FIVE (5) UNKNOWN SCREWS TO FIX S1. AFTER THE SURGEON OPENED THE PILOT HOLE BY USING A PEDICPROBE WITH SILICONE HAND INTO THE LOWER LEFT HOLE, THE SURGEON RECOGNIZED THAT THE TIP OF THE DEVICE WAS TWISTED. THEN, DURING AN INSERTION OF AN UNKNOWN SCREW INTO THE LOWER LEFT HOLE, THE SCREWDRIVER TIP BROKE AND THE BROKEN FRAGMENT WAS LEFT IN THE SCREW HEAD CORE. THE SURGEON COULD NOT REMOVE THE SCREW BECAUSE THE PATIENT'S BONE QUALITY WAS VERY HARD. THE SURGEON DECIDED TO LEAVE THE SCREW HEAD IN THE PATIENT'S BODY. THERE WAS NO SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 5). THIS REPORT IS FOR ONE (1) 3.0MM BIHEXAGONAL SCREWDRIVER WITH T-HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8237615 ↗
• InjuryMar 1, 2018Break; Break

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOW: IT WAS REPORTED THAT ON (B)(6) 2018, THE SURGERY FOR THE L3 FRACTURE WAS PERFORMED BY USING THE USS II ILIO-SACRAL SYSTEM. THE FIXED AREA WAS L3/ ILIUM. WHEN THE SCREW WAS INSERTED TO THE LEFT ILIUM, THE TIP OF THE SCREW DRIVER SHAFT WAS BROKEN. THE SCREW WAS REMOVED AND RE-INSERTED FROM A DIFFERENT PLACE. THE SURGERY WAS COMPLETED WITH A 60-MINUTE-DELAY, AND THERE WAS NO ADVERSE CONSEQUENCE (NO NERVOUS SYMPTOMS) TO THE PATIENT. COMPLAINT INVOLVES TWO (2) PARTS. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7308679 ↗
• MalfunctionSep 15, 2017Break; Break

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ONE TIP BROKEN OFF AND ONE TIP TWISTED. THIS OCCURED INTRAOPERATIVELY. NO FURTHER INFORMATION AVAILABLE AT THE MOMENT. THE ISSUE HAPPENED DURING A REVISION CASE WHERE SCREWS WERE REMOVED AND ALSO ADDED. THE SCREW WAS INSERTED INTO THE DENSE BONE AND GOT STUCK AND COULD NOT BE INSERTED OR REMOVED. THE PATIENT IS DOING WELL AND THE CASE WAS COMPLETED SUCCESSFULLY. THE SURGERY WAS NOT PROLONGED AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THERE IS NO ALLEGATION AGAINST THE SCREW. THE PROBLEM WAS WITH THE SCREWDRIVERS. THIS COMPLAINT INVOLVES 1 PART. CONCOMITANT REPORTED PART: UNKNOWN SCREWS. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6869729 ↗
• MalfunctionFeb 8, 2017Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOW: IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT UNDERWENT REVISION SURGERY TO REMOVE NAIL AFTER THE PELVIS FRACTURE SURGERY. THE SURGEON TRIED TO REMOVE A USS II (UNIVERSAL SPINAL SYSTEM) POLYAXIAL SCREW WHICH HAD BEEN INSERTED IN THE ILEUM. HOWEVER, BONE HAD ALREADY BEEN FORMED AROUND THE SCREW. THEREFORE, HE COULD NOT TURN THE REPORTED SCREWDRIVER HANDLE. WHEN HE PUT STRESS TO THE SCREWDRIVER, IT BROKE AND BENT. THERE IS NO INFORMATION AVAILABLE ABOUT PATIENT OUTCOME. THE SCREW WAS REMOVED, AND THE PROCEDURE COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE LEFT IN THE PATIENT¿S BODY. THE SURGERY WAS DELAYED FOR NINETY (90) MINUTES. PATIENT OUTCOME WAS NOT REPORTED. UPON RECEIPT OF THE DEVICE TO THE MANUFACTURER, IT WAS NOTED THAT THE SCREWDRIVER SHAFT WAS ALSO BROKEN. CONCOMITANT DEVICE: USS II POLYAXIAL SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). UNK NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 3.0MM BIHEXAGONAL SCREWDRIVER WITH T-HANDLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6310746 ↗