NA 311.006Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10887587035598), received between Oct 2, 2018 and Jun 8, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (13 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2026Break

  IT WAS REPORTED THAT A SCREWDRIVER IS BROKEN. IT FELL APART IN STERILE PROCESSING. IT BROKE AT THE HANDLE. THE WHOLE DRIVER CAME APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25435900 ↗
• MalfunctionMar 13, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE LOCKING MECHANISM OF THE SCREWDRIVER HANDLE WITH HEX COUPLING MEDIUM IS FAULTY AND CANNOT HOLD. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590634 ↗
• MalfunctionFeb 3, 2026Break

  IT WAS REPORTED THAT THE INSTRUMENT HAD BROKEN, THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24249474 ↗
• MalfunctionJul 14, 2025Break; Break

  IT WAS REPORTED THAT THE HANDLE WAS BROKEN. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22492979 ↗
• MalfunctionJun 30, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVER HANDLE WAS STICKY, MAKING IT CHALLENGING TO USE THE QUICK CONNECT, WHICH RESULTS IN THE DRIVER NOT BEING HELD PROPERLY AND FALLING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22358164 ↗
• MalfunctionFeb 18, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT GENIOPLASTY FOR JAW DEFORMITY ON MANDIBLE WITH THE HANDLE IN QUESTION. WHEN FASTENING A SCREW USING THE HANDLE IN QUESTION, THE HANDLE CAME APART WHILE BEING TURNED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21400477 ↗
• MalfunctionFeb 6, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT GENIOPLASTY FOR JAW DEFORMITY ON MANDIBLE WITH THE HANDLE IN QUESTION. WHEN FASTENING A SCREW USING THE HANDLE IN QUESTION, THE HANDLE CAME APART WHILE BEING TURNED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT OUTCOME IS REPORTED TO BE STABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21323274 ↗
• MalfunctionJul 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE ITEM WAS JAMMED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SCREWDRIVER HANDLE WITH HEX COUPLING-MEDIUM THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19719747 ↗
• MalfunctionFeb 13, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT THE HANDLE STAYS STUCK AND DOES NOT HOLD THE SCREWDRIVER PIECE. IT DID NOT AFFECT THE PATIENT. THIS REPORT IS FOR ONE (1) HANDLE MEDIUM W/HEX-COUPL, THIS IS REPORT 1 OF 1 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18697491 ↗
• MalfunctionJan 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED ON JANUARY 10 2024, THE SCREW DRIVER WAS STUCK TO THE HANDLE. THE PRODUCT DAMAGE DOCUMENTED HAD BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED. THIS REPORT IS FOR ONE (1) SCREWDRIVER HANDLE HEX COUPLING-MEDIUM THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18580237 ↗
• MalfunctionOct 2, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT DURING LOAN KIT INSPECTION, IT WAS IDENTIFIED THAT BOTH INSTRUMENTS GOT STUCK TOGETHER. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS REPORT IS FOR ONE (1) SCREWDRIVER HANDLE WITH HEX COUPLING-MEDIUM THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17854709 ↗
• MalfunctionAug 24, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6)2023, THE INSTRUMENT HANDLE BROKE. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SCREWDRIVER HANDLE WITH HEX COUPLING-MEDIUM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17612087 ↗
• MalfunctionMay 5, 2023Device-Device Incompatibility; Device-Device Incompatibility

  HOLD JT 5.5 DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT UPON USING THE MATRIX NEURO SCREWDRIVER HANDLE, THE SCREWDRIVER BLADE GOT JAMMED IN THE HANDLE AND WAS NOT ABLE TO BE DISENGAGED. THEREFORE, THE HANDLE AND BLADE NEED TO BE REPLACED. THERE IS NO PATIENT INVOLVEMENT, AND NO OTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) SCREWDRIVER HANDLE HEX COUPLING-MEDIUM THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16877886 ↗
• MalfunctionFeb 16, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, ONE OF THE SCREWDRIVER SHAFTS FROM A MANDIBLE COMPACT SET WAS FOUND WEDGED INSIDE OF A DRIVER HANDLE AND COULD NOT BE REMOVED. THERE WAS NO ADVERSE PATIENT IMPACT, NO SURGICAL DELAY DUE TO THIS EVENT. THE DRIVER SHAFT AND HANDLE WERE SEPARATED AT THE BEGINNING OF THE CASE, BUT COULD NOT BE SEPARATED AFTER THE PROCEDURE. THIS REPORT IS FOR A SCREWDRIVER HANDLE WITH HEX COUPLING-MEDIUM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16386006 ↗
• MalfunctionJun 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVER HANDLE COLLAR DO NOT CLOSE COMPLETELY AND NOT ALLOWING THE SCREWDRIVER BLADE TO SECURE IN THE RECESS. NO PATIENT OUTCOME WAS REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE SCREWDRIVER HANDLE HEX COUPLING-MEDIUM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14844439 ↗
• MalfunctionMar 30, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DEVICES WERE UNABLE TO BE REMOVED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) SCREWDRIVER HANDLE WITH HEX COUPLING-MEDIUM THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13956928 ↗
• MalfunctionMar 20, 2022Difficult to Remove; Physical Resistance/Sticking

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THERE WAS A REMOVAL SURGERY OF MANDIBLE PERFORMED ON FEBRUARY 18, 2022. IN THE SURGERY, THE SCREWDRIVER AND THE HANDLE WERE ATTACHED AND USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER SURGERY, THE SCREWDRIVER AND THE HANDLE WERE STUCK AND COULDN¿T BE DETACHED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SCREWDRIVER HANDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13829759 ↗
• MalfunctionDec 13, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A BILATERAL SAGITTAL SPLIT OSTEOTOMY (BSSO), THE SCREWDRIVER HANDLE CAME APART DURING SCREW INSERTION. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) SCREWDRIVER HANDLE WITH HEX COUPLING-MEDIUM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12984737 ↗
• MalfunctionAug 26, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE SCREWDRIVER HANDLE DISLODGED AND COULD NOT BE USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) SCREWDRIVER HANDLE WITH HEX COUPLING-MEDIUM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12369955 ↗
• MalfunctionFeb 23, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2021, TWO SCREWDRIVER HANDLES WITH HEX COUPLING NEEDED TO BE REMOVED FROM TWO MATRIXNEURO SCREWDRIVER SHAFTS AFTER PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE SCREWDRIVER HANDLE WITH HEX COUPLING-MEDIUM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11366542 ↗
• MalfunctionFeb 22, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NEW (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THE HOSPITAL NOTIFIED THAT AFTER EACH NEURO CLOSURE CASE, THE DRIVER ARE HAVING TO BE SENT DOWN TO ENGINEERING TO REMOVE THE HANDLE FROM THE SHAFT. THE PATIENT DOES NOT REQUIRE ANY REVISION SURGERY OR HARDWARE REMOVAL. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) SCREWDRIVER HANDLE WITH HEX COUPLING-MEDIUM. THIS IS REPORT 1 OF 2 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11362116 ↗
• MalfunctionDec 29, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2020, THE STERILE PROCESSING DEPARTMENT (SPD) STAFF INFORMED THAT THE SCREWDRIVER HANDLE WITH HEX COUPLING-MEDIUM WAS BROKEN AND CAN NO LONGER BE STERILIZED OR UTILIZED IN SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) SCREWDRIVER HANDLE WITH HEX COUPLING-MEDIUM. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11089792 ↗
• MalfunctionNov 4, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020 THAT STERILIZATION UNIT ARE REFUSING TO CLEAN INSTRUMENTS DUE TO SCREWDRIVER HANDLE IS NOT MEETING TESTING REQUIREMENTS BECAUSE THEY CANNOT FLUSH WATER ALL THE WAY THROUGH THE INSTRUMENT. THERE ARE NO PROCEDURE OR PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) SCREWDRIVER HANDLE WITH HEX COUPLING-MEDIUM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10787061 ↗
• MalfunctionMay 4, 2020Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE TWO (2) TRAYS; MATRIX MANDIBLE AND MATRIX MIDFACE TRAY WERE INSPECTED BECAUSE THE TRAYS HAD FALLEN FROM A SHELF IN THE STERILE PROCESSING DEPARTMENT (SPD). SEVERAL PARTS WERE NOTED TO BE DAMAGED IN THE TRAY. ONE (1) BONE REDUCTION FORCEP HAD A BROKEN FINE TIP, ONE (1) SCREWDRIVER HANDLE WAS BROKEN END CAP IS MISSING, ONE (1) MATRIX MANDIBLE DRILL GUIDE BROKEN TIP DAMAGE ON WHICH THE DRILL BIT WOULD NOT EASILY SLIDING THROUGH, AND ONE (1) T-HANDLE WAS BROKEN SLIDE IS VERY LOOSE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10020715 ↗
• MalfunctionJul 2, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE, THE SCREWDRIVER HANDLE WITH HEX COUPLING WAS BROKEN DOWN AND DID NOT RETURN TO ITS ORIGINAL STATE WHEN THE DEVICE WAS DROPPED ON THE FLOOR. THERE WAS NO SURGICAL DELAY REPORTED. PATIENT AND PROCEDURE OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) SCREWDRIVER HANDLE WITH HEX COUPLING-MEDIUM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8755470 ↗