NA 03.620.064Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034717807), received between Feb 22, 2017 and Apr 17, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A SPINAL FUSION PROCEDURE USING A SCREWDRIVER SHAFT WITH HANDLE TO LOCK THE FOUR (4) MATRIX LOCKING CAPS. HOWEVER, AFTER FINAL TIGHTENING OF THE SECOND SET SCREW, THE SCREWDRIVER SHAFT BROKE OFF. ONE FRAGMENT WAS FOUND AND EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY HAND TIGHTENING WITH ANOTHER SCREWDRIVER. THERE WAS NO SURGICAL DELAY REPORTED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN MATRIX LOCKING CAPS (PART # 09.632.099 , LOT # UNKNOWN, QUANTITY 4), T-HANDLE WITH RATCHET WRENCH (PART # 03.620.061, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) SCREWDRIVER SHAFT T25 STRAIGHT TIP/6MM HXC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8522725 ↗
• MalfunctionMar 22, 2019Break; Material Twisted/Bent; Break; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING A 4 LEVEL TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) FOR L2-S1 STENOSIS, THE SCREWDRIVER SHAFT BROKE INTO PIECES WHILE TIGHTENING. DURING THE PROCEDURE, THE SCREWDRIVER SHAFT WITH A 10NM TORQUE LIMITING RACHET HANDLE MADE A STRANGE SOUND DURING FINAL TIGHTENING AS THE SCREWDRIVER TIP WAS NOT FULLY ENGAGED TO THE SET SCREW ON SCREW HEAD WHILE TIGHTENING, THUS, EXTRA STRENGTH TO TORQUE THAN USUAL WAS REQUIRED. THE SURGEON MANAGED TO TORQUE THE FIRST TWO (2) UNKNOWN SCREWS WITH A FUNNY SOUND WITH AN EXTRA EFFORT, BUT WHILE TIGHTENING ON THE THIRD UNKNOWN SCREW, THE TIP OF THE SCREWDRIVER SHAFT BROKE INTO PIECES. AS A RESULT, THE SURGEON USED AN ALTERNATIVE SCREWDRIVER SHAFT TO FINISH OFF THE REST OF THE SCREWS. THE SURGEON CLAIMED THAT THE THREAD ON SCREWDRIVER SEEMED SLIGHTLY TWISTED BEFORE USED. FRAGMENTS WERE EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF TEN (10) MINUTES. THERE WAS NO REPORTED PATIENT IMPACT. CONCOMITANT DEVICE/S REPORTED: UNKNOWN SCREWS (PART# UNKNOWN. LOT# UNKNOWN, QUANTITY 3)

  Patient problems: Not Applicable

  MAUDE report 8446177 ↗
• MalfunctionJan 15, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A SCHEDULED SPINE REVISION SURGERY ON (B)(6) 2017, THE SCREWDRIVER BROKE DURING THE REMOVAL OF THE SETSCREW. SURGEON AND NURSE CONFIRMED THAT ALL BROKEN PARTS WERE REMOVED. NO BROKEN PARTS LEFT IN THE PATIENT'S BODY. SURGEON NEEDED TO REMOVE THE ROD AND INSERT FEW MORE SCREWS DURING THE SCHEDULED HARDWARE REMOVAL SURGERY. THERE WAS NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7189255 ↗
• MalfunctionJun 27, 2017Dull, Blunt; Dull, Blunt

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED TWO (2) SCREWDRIVER SHAFTS WERE REPORTED TO BE WORN AND DULL AND WERE REMOVED FROM SERVICE. NO PATIENT OR SURGERY INVOLVEMENT. EVALUATION OF THE DEVICES REVEALED THE TIPS ARE STRIPPED. THIS REPORT IS FOR ONE (1) STRAIGHT TIP SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6670191 ↗
• MalfunctionFeb 22, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT UNDERWENT A MATRIX HARDWARE REMOVAL AND EXTENSION FUSION PROCEDURE OF L3-4. DURING THE PROCEDURE, THE FACTORY TORQUE LOOSENED ON TWO T-HANDLE SCREWDRIVERS AND THE SHAFT WAS UNSCREWED FROM THE HANDLE. ALSO DURING THIS PROCEDURE, THE TIP BROKE ON BOTH A SCREWDRIVER SHAFT T25 STRAIGHT TIP/6MM HXC AND A STRAIGHT TIP T25 DRIVER STANDARD. THE ORIGINAL PROCEDURE TO IMPLANT A MATRIX SYSTEM ON L4-5 WAS PERFORMED ON AN UNKNOWN DATE. THE PATIENT HEALED SUCCESSFULLY. THE PROCEDURE ON (B)(6) 2017 WAS PLANNED IN RESPONSE TO DEGENERATIVE DISC DISEASE ON THE LEVEL ADJACENT TO THE OLD FUSION. ALL FRAGMENTS WERE EASILY REMOVED WITHOUT ANY ADDITIONAL INTERVENTION. THERE WAS A FIVE MINUTE DELAY. THE REMOVED INTACT CONSTRUCT INCLUDED TWO MATRIX 6.0X45 SCREWS, TWO CAPS AND TWO 45MM RODS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICES REPORTED: MATRIX 6.0X45 SCREWS (PART # 04.632.645, LOT # UNKNOWN, QUANTITY 2); LOCKING CAPS (PART # 04.632.000, LOT # UNKNOWN, QUANTITY 2); 45MM RODS (PART # 04.636.045, LOT# UNKNOWN, QUANTITY 2). THE EVENT THAT LED TO THE REVISION SURGERY IS CAPTURED IN (B)(4). THIS REPORT CAPTURES THE EVENT THAT OCCURRED DURING T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6348944 ↗