NA 311.007Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10887587035604), received between Apr 19, 2019 and Feb 27, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BLACK HANDLE PIECE WAS LOOSE. WHEN YOU PULL THE FINGER PIECE TO PUT THE BLADE IN, IT WON'T LATCH IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470601 ↗
• MalfunctionMay 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  THE INITIAL COMPLAINT WAS REVIEWED AND DETERMINED TO BE NOT REPORTABLE, AS THIS COMPLAINT WAS A DUPLICATE. THE MALFUNCTION OF THE SCREWDRIVER HANDLE WITH HEX COUPLING-LARGE WAS ALREADY REPORTED IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16974954 ↗
• MalfunctionFeb 10, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UK AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE SCREWDRIVER HANDLE WAS BROKEN ON SET. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) HANDLE-LRG W/HEX-COUPL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16352744 ↗
• MalfunctionDec 30, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DAY IN (B)(6) 2022, THE BLADE OF THE LARGE HANDPIECE WITH HEXAGONAL COUPLING DID NOT HOLD PROPERLY. THERE WAS NO PATIENT HARM. THERE WAS NO DELAY IN SURGERY, AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SCREWDRIVER HANDLE WITH HEX COUPLING-LARGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16077286 ↗
• MalfunctionMar 29, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN TAIWAN AS FOLLOWS: IT WAS REPORTED THAT LESS THAN HALF A YEAR AFTER THE INSTRUMENT WAS PLACED IN THE HOSPITAL, THE METAL PART OF THE BOTTOM WAS LOOSE SO THAT THE FRONT PART COULD NOT BE PRESSED DOWN THAT CAUSED THE SCREWDRIVER SHAFT COULD NOT BE CONNECTED. IT HAS BEEN CONFIRMED THAT THE DEVICE HAS NOT BEEN MANIPULATED IMPROPERLY, AND THIS SITUATION IS VERY RARE. THIS COMPLAINT INVOLVES ONE (1) DEVICE HANDLE-LRG W/HEX-COUPL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13939689 ↗
• MalfunctionJan 22, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE AFTER UNPACKING THE PRODUCT, IT WAS FOUND TO BE BROKEN INTO THREE (3) PARTS. WHEN IT IS ASSEMBLED AND THE TOP IS PRESSED, THE END PARTS ARE EXPOSED. THIS REPORT IS FOR ONE (1) SCREWDRIVER HANDLE WITH HEX COUPLING-LARGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11214280 ↗
• MalfunctionApr 21, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE SHAFT OF THE SCREWDRIVER BECAME STUCK. THE HANDLE WAS NOT ABLE TO BE SEPARATED FROM THE SHAFT AND THE HANDLE BROKE. THE PATIENT WAS NOT AFFECTED, AND THERE WAS NO REPORTED DELAY TO THE SURGERY. ANOTHER SET WAS USED TO COMPLETE THE SURGERY. CONCOMITANT DEVICES REPORTED: SCREWDRIVER HANDLE WITH HEX COUPLING-LARGE (PART NUMBER 311.007, LOT T984539, QUANTITY 1), SCREWDRIVERS: SHAFTS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) SCREWDRIVER HANDLE WITH HEX COUPLING-LARGE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9980687 ↗
• MalfunctionApr 20, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE SHAFT OF THE SCREWDRIVER BECAME STUCK. THE HANDLE WAS NOT ABLE TO BE SEPARATED FROM THE SHAFT AND THE HANDLE BROKE. THE PATIENT WAS NOT AFFECTED, AND THERE WAS NO REPORTED DELAY TO THE SURGERY. ANOTHER SET WAS USED TO COMPLETE THE SURGERY. CONCOMITANT DEVICES REPORTED: SCREWDRIVER HANDLE WITH HEX COUPLING-LARGE (PART NUMBER 311.007, LOT T984539, QUANTITY 1), SCREWDRIVERS: SHAFTS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) SCREWDRIVER HANDLE WITH HEX COUPLING-LARGE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9977559 ↗
• MalfunctionOct 24, 2019Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THE ROTATING PORTION OF THE SCREWDRIVER HANDLE (PART #311.007) BROKE OFF AND CAME APART. THERE WERE NO FRAGMENTS CREATED AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER CONSEQUENCES. THIS REPORT IS FOR ONE (1) HANDLE-LRG W/HEX-COUPL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9234654 ↗
• MalfunctionApr 19, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A ROUTINE FIELD INSPECTION ON UNKNOWN DATE, ONE (1) SCREWDRIVER HANDLE WITH HEX COUPLING-LARGE AND ONE (1) SCREWDRIVER BLADE WOULD NOT COME APART FROM EACH OTHER. ONE (1) LOW PROFILE NEURO COMPACT MODULE WOULD NOT SHUT. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT. THIS REPORT IS FOR A SCREWDRIVER HANDLE WITH HEX COUPLING-LARGE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8533250 ↗