NA 310.95Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10886982187147), received between Apr 24, 2019 and Apr 1, 2025 — classified as 16 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CRUCIFORM SCREWDRIVER SHAFT WITH HOLDING SLEEVE (314.67) IS THAT IT'S NOT ABLE TO BE SECURED LOCKED INTO THE QUICK COUPLING HANDLES IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED. IT IS UNKNOWN IF THERE IS PATIENT INVOLVEMENT. IT IS UNKNOWN IF REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21742532 ↗
• MalfunctionOct 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS A PRE OPERATIVE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20346289 ↗
• MalfunctionSep 27, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE DENTAL COUPLING WOULD NOT ADAPT THE SCREWDRIVERS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER A DELAY OF 20 MINUTES. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A HANDLE WITH MINI QUICK COUPLING, STAINLESS STEEL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15495186 ↗
• MalfunctionJul 25, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON BROKE A SCREWDRIVER IN THE SCREWDRIVER HANDLE. THERE WERE NO FRAGMENTS RETAINED IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE HANDLE WITH MINI QUICK COUPLING, STAINLESS STEEL. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15093839 ↗
• MalfunctionJun 30, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HANDLE WITH THE MINI QUICK COUPLING WOULD NOT HOLD A BIT SECURELY. IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED. PATIENT INVOLVEMENT IS UNKNOWN. IT IS UNKNOWN IF REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION OCCURRED. THIS REPORT IS FOR ONE (1) HNDL MINI QC, STAINLESS STEEL THIS IS REPORT 1 OF 1 FOR COMPLAINT PC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14880774 ↗
• MalfunctionMay 10, 2021Device-Device Incompatibility; Device-Device Incompatibility

  THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11796985 ↗
• MalfunctionMay 10, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING CLEANING, THE TECHNICIAN NOTICED THAT THE SCREW SHAFTS WOULD NOT CONNECT OR STAY IN WHEN INSERTED TO BOTH HANDLES WITH MINI QUICK COUPLING, STAINLESS STEEL. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) HANDLE WITH MINI QUICK COUPLING, STAINLESS STEEL. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11796974 ↗
• MalfunctionJan 8, 2021Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING FRACTURE REPAIR, THE HANDLE WITH MINI QUICK COUPLING WAS MISSING A PIECE. IT WAS NOTICED WHEN THE SURGEON IS UNABLE TO UNSCREW AN UNKNOWN SCREW THAT HAD ALREADY BEEN PLACED. IT WAS COMPLETED THE SURGEONS USED AN ALTERNATIVE SCREWDRIVER HANDLE. THE REASON FOR REMOVAL OF THE SCREW WAS UNKNOWN "KELY" DUE TO AN ISSUE WITH SCREW LENGTH. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: SCREW: TRAUMA (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). SCREWDRIVERS: TRAUMA (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) HANDLE WITH MINI QUICK COUPLING, STAINLESS STEEL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11139609 ↗
• MalfunctionDec 15, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE HANDLES BROKE. THIS REPORT IS FOR ONE (1) HANDLE WITH MINI QUICK COUPLING, STAINLESS STEEL. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11011716 ↗
• MalfunctionDec 15, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE HANDLES BROKE. THIS REPORT IS FOR ONE (1) HANDLE WITH MINI QUICK COUPLING, STAINLESS STEEL. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11011636 ↗
• MalfunctionJun 22, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2020, DURING TESTING, IT WAS OBSERVED THAT THE HANDLE WITH MINI QUICK COUPLING WOULD NOT HOLD. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES 1 DEVICE. THIS REPORT IS FOR 1 HANDLE WITH MINI QUICK COUPLING, STAINLESS STEEL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10182594 ↗
• MalfunctionJun 8, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE HANDLE WITH MINI QUICK COUPLING, STAINLESS STEEL WOULD NOT HOLD ONTO THE DRIVER SHAFT. THEY WERE REMOVED FROM THE SCREW REMOVAL TRAY. ANOTHER TRAY WAS OPENED, AND THE SURGEON USED THE HANDLE FROM THERE. PROCEDURE AND PATIENT OUTCOMES ARE UNKNOWN. CONCOMITANT DEVICES: SCREWDRIVER SHAFT (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A HANDLE WITH MINI QUICK COUPLING, STAINLESS STEEL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10127986 ↗
• MalfunctionJun 5, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, TWO (2) HANDLES WOULD NOT HOLD ONTO THE DRIVER SHAFTS. THEY WERE REMOVED FROM THE SCREW REMOVAL TRAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES: SCREWDRIVER SHAFT (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1) THIS REPORT IS FOR A HANDLE WITH MINI QUICK COUPLING, STAINLESS STEEL. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10123077 ↗
• MalfunctionApr 17, 2020Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICE REPORTED: SCREWDRIVER SHAFT (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), DRILL BITS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9971766 ↗
• MalfunctionMay 31, 2019Device-Device Incompatibility; Device-Device Incompatibility

  MINI QUICK COUPLING, STAINLESS STEEL DURING SET UP. ISSUE WAS IDENTIFIED AND RESOLVED BEFORE PATIENT INVOLVEMENT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACKUP DEVICE. THIS REPORT IS FOR A HANDLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8659302 ↗
• MalfunctionApr 24, 2019Device-Device Incompatibility; Device-Device Incompatibility

  VETERINARY COMPLAINT: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN INITIAL IMPLANT TO REPAIR A FRACTURE, A HANDLE WITH MINI QUICK COUPLING WAS NOT LOCKING INTO THE HANDLE. IT WAS NOTED THAT IT FITS ON THE SHAFT FINE, BUT THE SLEEVE WILL NOT GRASP. IT WAS ALSO REPORTED THAT THE SCREWDRIVER WAS NOT GRABBING SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF APPROXIMATELY SIXTY (60) MINUTES. THERE WAS NO IMPACT TO THE PATIENT. IT WAS FURTHER REPORTED THAT DEVICES WERE NOT WORKING APPROPRIATELY SINCE THEY HAVE HAD THEM. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) HANDLE WITH MINI QUICK COUPLING, STAINLESS STEEL. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8545418 ↗