NA 03.614.018Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705034714899), received between Feb 28, 2017 and Apr 27, 2026 — classified as 7 malfunctions.

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

• MalfunctionApr 27, 2026Material Integrity Problem

  IT WAS REPORTED THAT BOTH THE T EXTENSION PIECES OF THE SCREWDRIVER SNAPPED OFF INTRAOPERATIVELY WHILE REMOVING SYNAPSE SCREWS. THE BROKEN PIECES ENTERED THE PATIENT BUT WERE SUBSEQUENTLY RECOVERED IN THE SUCTION FILTER. THERE WAS NO REPORTED PATIENT HARM OR SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000364 ↗
• MalfunctionJan 5, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DAY IN (B)(6) 2020 DURING AN UNKNOWN PROCEDURE, THE SCREWDRIVER WAS BROKEN. BOTH TRANSVERSE PROJECTIONS HAD BROKEN OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER SCREWDRIVER. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) CROSS PINNED STRDRV SCRWDRVR SHAFT SELF-RETAINING T15/QC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11116559 ↗
• MalfunctionDec 11, 2020Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, UPON REGULAR CLEANING AND INSPECTION OF INSTRUMENTS, IT WAS IDENTIFIED THAT THE SYNAPSE STARDRIVE SCREWDRIVER SHAFT HAD MICRO FRACTURES AT THE TIP OF THE SHAFT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CROSS PINNED STRDRV SCRWDRVR SHAFT SELF-RETAINING T15/QC. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10991667 ↗
• MalfunctionDec 11, 2020Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, UPON REGULAR CLEANING, AND INSPECTION OF INSTRUMENTS, IT WAS IDENTIFIED THAT THE SYNAPSE STAR DRIVE SCREWDRIVER SHAFT HAD MICRO FRACTURES AT THE TIP OF THE SHAFT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CROSS PINNED STRDRV SCREWDRIVER SHAFT SELF-RETAINING T15/QC. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10991660 ↗
• MalfunctionMar 20, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT WHILE TESTING THE TORQUE HANDLE ON (B)(6) 2017, THE CROSS PINNED STRARDRIVE SCREWDRIVER FRACTURED AND THE TIP BROKE OFF. THE EVENT OCCURRED OUTSIDE THE OPERATING ROOM. THERE WAS NO PATIENT INVOLVEMENT. PLEASE SEE RELATED COMPLAINT, COM-(B)(4), THAT ADDRESSES AND REPORTS THE TORQUE LIMITING HANDLES. THIS REPORT IS 1 OF 1 FOR COM-(B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6419490 ↗
• MalfunctionMar 3, 2017Break; Break

  IT WAS REPORTED BY SERVICE AND REPAIR DEPARTMENT THAT SYNTHES EVALUATION EQUIPMENT - TIP IS BROKEN - ISSUE IDENTIFIED DURING INSPECTION ACTIVITIES OF THE EVALUATION SET. THERE WERE NO ISSUES REPORTED BY THE CUSTOMER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6377792 ↗
• MalfunctionFeb 28, 2017Break; Crack; Break; Crack

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2017, PRE-OPERATIVELY AS THE OPERATING ROOM NURSE WAS SETTING UP THE STERILE TABLE FOR A SPINE CERVICAL FUSION PROCEDURE, IT WAS NOTED THAT THE END TIP OF THE SCREWDRIVER WAS CRACKED. NO ADDITIONAL TIME WAS ADDED AND ANOTHER BACKUP SCREWDRIVER WAS AVAILABLE IN THE OPERATING ROOM. NO PATIENT HARM. DURING THE MANUFACTURER INVESTIGATION PROCESS IT WAS ALSO IDENTIFIED THAT THE TIP OF THE SCREWDRIVER IS BROKEN AND MISSING A FRAGMENT. THIS CONDITION WAS RE-EVALUATED AND DETERMINED TO BE REPORTABLE ON (B)(6) 2017. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6363929 ↗