NA 698337505Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705034377261), received between Sep 28, 2018 and Nov 14, 2024 — classified as 3 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (8 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2024Material Deformation; Material Deformation

  IT WAS REPORTED ON (B)(6) 2024 WHILE SETTING UP FOR A CASE, THE SCRUB NURSE NOTICED THE TIP OF THE SHORT T20 DRIVER WAS BURRED. THERE IS A SECOND ONE OF THESE ITEMS ON THE SET, SO THE DAMAGED ONE WAS PUT ASIDE AND A GOOD ONE WAS USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683812 ↗
• MalfunctionJun 4, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON 08-MAY-2024, THE TIP OF THE INSTRUMENT WAS BURRED OFF. THIS WAS IDENTIFIED DURING LOAN KIT INSPECTION NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE MODIFIED INSTRUMENT DRIVER, SHORT T20. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458720 ↗
• MalfunctionMar 29, 2024Material Deformation; Material Deformation

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 13-MARCH-2024 DURING LOAN KIT INSPECTION, THE TIP OF THE DRIVER IN QUESTION WAS FOUND TO BE BURRED. THERE WAS NO PATIENT OR PROCEDURE INTERACTION, THIS EVENT WAS DISCOVERED OUTSIDE OF SURGERY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MODIFIED INSTRUMENT DRIVER, SHORT T20. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19006657 ↗
• InjuryJul 10, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE T20 SCREWDRIVER SHAFT IN QUESTION WAS BEING USED TO ADVANCE A SCREW AND THE TIP OF THE SCREWDRIVER BROKE OFF. THE TIP OF THE SCREWDRIVER REMAINED LODGED IN THE HEAD OF THE SHAFT OF THE SCREW. THE SURGEON LOCKED THE SCREWDRIVER TIP INTO THE SCREW SHAFT WITH A ROD AND SET SCREW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. THERE IS NO FURTHER INFORMATION TO REPORT. THIS REPORT IS FOR A MODIFIED INSTRUMENT DRIVER, SHORT T20. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 17291341 ↗
• MalfunctionJun 8, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT DURING A SPINAL FUSION SURGERY ON (B)(6) 2023, THE TIP OF THE SHORT T25 DRIVER BROKE OFF. THERE WAS A SECOND DRIVER ON THE SET THAT WAS USED FOR THE REMAINDER OF THE CASE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE MODIFIED INSTRUMENT DRIVER, SHORT T20. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17085904 ↗
• MalfunctionJun 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SCRUB NURSE WAS SETTING UP FOR A T10-PELVIS FUSION FOR SURGEON USING THE CONSIGNMENT EXPEDIUM SET. WHILE SETTING UP SHE WAS UNABLE TO ATTACH THE SHORT T20 SCREWDRIVER INTO THE HUDSON ADAPTOR. THERE WAS ANOTHER SHORT T20 DRIVER ON THE SET SO THE DAMAGED ONE WAS PUT TO THE SIDE AND THE 2ND ONE WAS USED INSTEAD AND IT ATTACHED AS NORMAL. THE SCREWDRIVER IN QUESTION SHOWS THE END, THAT ATTACHES TO THE HUDSON ADAPTOR, HAS 2 SMALL INDENTS JUST BELOW THE GROOVE THAT NORMALLY WOULD LOCK INTO THE ADAPTOR. THERE WAS NO REPORTED SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) MODIFIED INSTRUMENT DRIVER, SHORT T20. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14632339 ↗
• InjuryDec 15, 2021Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE TIP OF THE T20 DRIVER BROKE OFF IN THE SHAFT OF THE SCREW AND COULD NOT BE REMOVED. THE SURGERY WAS COMPLETED WITHOUT SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED. DI POLYAXL SCREW 8 X 65MM (PART # 179722865, LOT # UNKNOWN, QTY 2), SI POLYAXL SCREW 7 X 40MM (PART # 179722000, LOT # UNKNOWN, QTY 2), EXP DUAL-INNER SET SCREW (PART # 179793050, LOT # UNKNOWN, QTY 2), TI FIXED LAT CONNECTOR 50MM (PART # 179712740, LOT # UNKNOWN, QTY 3), SI POLYAXL SCREW 7 X 35MM (PART # 179712735, LOT # UNKNOWN, QTY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) MOD T20 DRIVER SHORT. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13014252 ↗
• MalfunctionDec 9, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, THE SURGEON WAS INSERTING THE SCREW WHEN THE TIP/END OF THE SCREWDRIVER SHAFT BROKE OFF IN THE HEAD OF THE SCREW. THERE WERE NO FRAGMENTS AND THE SURGEON CONTINUED WITH THE OPERATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) MODIFIED INSTRUMENT DRIVER, SHORT T20. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12969131 ↗
• MalfunctionSep 16, 2021Break; Material Deformation; Break; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 WHILE USING THE SCREWDRIVER SHAFT ON POWER, TO ADVANCE A PEDICLE SCREW INTO THE PELVIS THE TIP BROKE IN THE SHAFT OF THE SCREW. THE SCREW WAS REMOVED WHICH HAD THE TIP OF THE SCREWDRIVER IN THE SHAFT OF THE SCREW. ANOTHER SCREW WAS PLACED WITH NO ISSUE USING THE 2ND SHORT SCREWDRIVER ON POWER AGAIN, TO ADVANCE THE SCREW AND IT WAS NOTED THAT THE TIP WAS BURRED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) MODIFIED INSTRUMENT DRIVER, SHORT T20. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12481814 ↗
• MalfunctionSep 16, 2021Break; Material Deformation; Break; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 WHILE USING THE SCREWDRIVER SHAFT ON POWER, TO ADVANCE A PEDICLE SCREW INTO THE PELVIS THE TIP BROKE IN THE SHAFT OF THE SCREW. THE SCREW WAS REMOVED WHICH HAD THE TIP OF THE SCREWDRIVER IN THE SHAFT OF THE SCREW. ANOTHER SCREW WAS PLACED WITH NO ISSUE USING THE 2ND SHORT SCREWDRIVER ON POWER AGAIN, TO ADVANCE THE SCREW AND IT WAS NOTED THAT THE TIP WAS BURRED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) MODIFIED INSTRUMENT DRIVER, SHORT T20. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12481782 ↗
• MalfunctionAug 6, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING THE PROCEDURE, THE T20 SHORT DRIVER BURRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SAME LIKE PRODUCT. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) MOD T20 DRIVER SHORT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12287624 ↗
• InjuryDec 31, 2020Entrapment of Device; Appropriate Device Problem Term/Code Not Available; Entrapment of Device; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, WHEN SCREWING DOWN SCREW THE TIP OF T20 SHORT DRIVER BROKE OFF AND STUCK IN HEAD OF SCREW. ALSO, TORQUE DRIVER BURRED AT TIP. UNABLE REMOVE TIP OF SCREW. THE SURGERY COMPLETED SUCCESSFULLY WITHOUT DELAY. THERE WERE NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) MOD T20 DRIVER SHORT. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11102825 ↗
• MalfunctionDec 22, 2020Material Deformation; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020 THAT DURING AN UNKNOWN SURGERY THE SURGEON USED THE SHORT T20 SCREWDRIVER SHAFT AND NOTED THAT IT WAS SLIPPING. SURGEON USED THE 2ND SET OF THE INSTRUMENT. ON INSPECTION IT WAS DETERMINED THAT BOTH SHORT T20 SCREWDRIVER SHAFTS WERE NOTED TO BE BURRED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. THERE WERE NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) MOD T20 DRIVER SHORT. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11059933 ↗
• MalfunctionDec 22, 2020Material Deformation; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020 THAT DURING AN UNKNOWN SURGERY THE SURGEON USED THE SHORT T20 SCREWDRIVER SHAFT AND NOTED THAT IT WAS SLIPPING. SURGEON USED THE 2ND SET OF THE INSTRUMENT. ON INSPECTION IT WAS DETERMINED THAT BOTH SHORT T20 SCREWDRIVER SHAFTS WERE NOTED TO BE BURRED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. THERE WERE NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) MOD T20 DRIVER SHORT. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11059840 ↗
• MalfunctionNov 12, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  THE FOLLOWING WAS REPORTED: T10-PELVIS; ((B)(6) (B)(6) 2018. DR (B)(6) WAS INSERTING PEDICLE SCREWS UNDER POWER AND THE TIP OF THE T20 SCREWDRIVER SHAFT (SHORT))WAS BURRED. HE ASKED THAT IT BE REPLACED. DR (B)(6) WAS USING THE BALL TIP FEELER TO FIND THE ENTRY POINT INTO THE PEDICLE TO PLACE THE SCREW, ( THIS IS HIS STANDARD OPERATING PROCEDURE) AND HE BENT THE TIP OF THE FEELER. HE ASKED THAT IT BE REPLACED. THERE WAS NO DELAY IN SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8059628 ↗
• MalfunctionSep 28, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  SELECTIVE THORACIC FUSION; (B)(6), (B)(6) HOSPITAL (B)(6) (B)(6) 2018. DR (B)(6) WAS INSERTING PEDICLE SCREWS UNDER POWER AND THE TIP OF THE T20 SCREWDRIVER SHAFT (SHORT)) WAS BURRED. HE ASKED THAT IT BE REPLACED. THERE WAS NO DELAY IN SURGERY. ACTION TAKEN: THERE ARE X 2 INSTRUMENTS ON THE SET AND THE 2ND ONE WAS USED. NO AE TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7920211 ↗
• MalfunctionSep 28, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  REMOVAL OF ILIAC SCREWS FROM EXISTING CONSTRUCT - L4-PELVIS; (B)(6), (B)(6) HOSPITAL (B)(6) 2018. DR (B)(6) WAS INSERTING PEDICLE SCREWS UNDER POWER AND THE TIP OF THE T20 SCREWDRIVER SHAFT (SHORT) WAS BURRED. HE ASKED THAT IT BE REPLACED. NO DELAY TO SURGERY. NO AE TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7920186 ↗
• MalfunctionSep 28, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  REMOVAL OF ILIAC SCREWS FROM EXISTING CONSTRUCT - L4-PELVIS; (B)(6), (B)(6) HOSPITAL (B)(6) 2018. DR (B)(6) WAS INSERTING PEDICLE SCREWS UNDER POWER AND THE TIP OF THE T20 SCREWDRIVER SHAFT (SHORT)) WAS BURRED. HE ASKED THAT IT BE REPLACED. NO DELAY TO SURGERY. NO AE TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7920119 ↗