NA 311.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 10886982187192), received between Jan 18, 2017 and Mar 26, 2026 — classified as 1 injury, 105 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (75 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 106 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE QUICK CONNECTION ON THE FRONT TIP OF THE DEVICE HAD BECOME STUCK AND COULD NO LONGER SUCCESSFULLY CONNECT WITH SCREWDRIVER SHAFTS AS INTENDED. THIS ITEM WAS DEEMED TO BE NO LONGER FUNCTIONAL AND WAS SUBSEQUENTLY DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699986 ↗
• MalfunctionMar 26, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE QUICK CONNECTION ON THE FRONT TIP OF THE DEVICE HAD BECOME STUCK AND COULD NO LONGER SUCCESSFULLY CONNECT WITH SCREWDRIVER SHAFTS AS INTENDED. THIS ITEM WAS DEEMED TO BE NO LONGER FUNCTIONAL AND WAS SUBSEQUENTLY DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699979 ↗
• MalfunctionMar 9, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THAT POSTOPERATIVELY IT WAS IDENTIFIED THAT THE DEVICE IS BROKEN AND THE HANDLE WON'T LATCH ONTO SCREWDRIVERS, THE SYNTHETIC WOOD CHIPPED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545570 ↗
• MalfunctionMar 9, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THAT POSTOPERATIVELY IT WAS IDENTIFIED THAT THE DEVICE IS BROKEN AND THE HANDLE WON'T LATCH ONTO SCREWDRIVERS, THE SYNTHETIC WOOD CHIPPED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545563 ↗
• MalfunctionDec 12, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE HANDLE NO LONGER GRIPS/RETAINS DRIVER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794683 ↗
• MalfunctionDec 11, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON NOV 21, 2025, HANDLE WILL NOT HOLD DRIVER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783271 ↗
• MalfunctionJul 29, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE HANDLE WITH MINI QUICK COUPLING FROM THE LCP MODULAR MINI SET WILL NOT HOLD THE SCREWDRIVER SHAFT. THE COUPLING PART OF HANDLE WAS NOT WORKING. HANDLE WOULDN¿T HOLD THE THE POWER SCREWDRIVER. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22641510 ↗
• MalfunctionJul 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE SCREW DRIVERS AND ONE HANDLE ARE BROKEN, NEED REPLACEMENT ASAP. DRIVER TIPS ARE TWISTED AND HAVE DAMAGED THREADS. SCREW DRIVER HANDLE IS STUCK AND WILL NOT RELEASE. ITEMS ARE AVAILABLE FOR RETURN. NO DELAY OR PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22577332 ↗
• MalfunctionJun 30, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE HANDLE NO LONGER LOCKS THE SCREW DRIVER IN PLACE PROPERLY OR TWISTS HANDLE PROPERLY TO TIGHTEN SCREW. ISSUE WAS IDENTIFIED POSTOPERATIVELY.

  Patient problems: Insufficient Information

  MAUDE report 22358018 ↗
• MalfunctionMay 8, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE ITEM IS NOT FUNCTIONING PROPERLY. THE HANDLE WOULD NOT ACCEPT AND HOLD ONTO SCREWDRIVER TIPS. ISSUE WAS DISCOVERED DURING SURGERY; THERE WAS NO PATIENT INVOLVEMENT OR DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986173 ↗
• MalfunctionMay 6, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE REP WAS PROVIDING AN INSERVICE TO THE STAFF AND NOTICE THE SCREWDRIVER COUPLER WAS BROKEN. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21969872 ↗
• MalfunctionJan 16, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025 THE DRIVER SHAFTS WILL NOT ENGAGE WITH QUICK CONNECT HANDLE. IT WAS FOUND POST-OP. THERE WAS NO PATIENT INVOLVEMENT OR DELAY IN CASE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21170231 ↗
• MalfunctionJan 14, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENTS BROKE IN DECONTAMINATION AND THE DAMAGE WAS NOTICED DURING INSPECTION. THE EVENT OCCURRED DURING STERILE PROCESSING, CALIBRATION AND FIELD INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21150586 ↗
• MalfunctionDec 31, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE METRO TRAY CAME BACK FROM THE CASE WITH THE SCREWDRIVER SHAFT WEDGED INTO THE HANDLE. IT IS NOT POSSIBLE TO REMOVE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047920 ↗
• MalfunctionDec 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 THE HANDLE STUCK TO DRIVESHAFT. THE EVENT OCCUR DURING STERILE PROCESSING AND FIELD INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20920024 ↗
• MalfunctionNov 21, 2024Device-Device Incompatibility; Illegible Information; Device-Device Incompatibility; Illegible Information

  IT WAS REPORTED THAT ON (B)(6) 2024, A HANDLE WITH MINI QUICK COUPLING WOULD NOT ENGAGE THE MINI SCREWDRIVERS IN THE MINI FRAG. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20751567 ↗
• MalfunctionOct 22, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE SCREWDRIVER HANDLES ARE LEAVING BROWN MARKS IN POUCHES AFTER STERILIZATION. THE HANDLES ARE CREATING DEBRIS. THE EVENT OCCURRED DURING FIELD INSPECTION AND STERILE PROCESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20507490 ↗
• MalfunctionAug 23, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SCREWDRIVER HANDLE AND T6 DRIVER DID NOT ATTACH TOGETHER FOR SOME REASON. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT OUTCOME REPORTED. THIS REPORT INVOLVES ONE (1) HANDLE WITH MINI QUICK COUPLING. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20051496 ↗
• MalfunctionAug 21, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT AN VETERINARY PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, THE HANDLE WAS NOT TIGHTENING. BACK UP WAS AVAILABLE. SURGERY WAS COMPLETED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THIS REPORT IS FOR A HANDLE WITH MINI QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20009918 ↗
• MalfunctionAug 8, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE QC CONNECTION WAS BROKEN ON THE ITEM. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT INVOLVES ONE HANDLE WITH MINI QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939732 ↗
• MalfunctionJun 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE THE HANDLE DOES NOT LATCH ONTO THE DRIVER. THE EVENT OCCUR DURING STERILE PROCESSING, FIELD INSPECTION AND CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE (1) HANDLE WITH MINI QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19524039 ↗
• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED THAT ON FEBRUARY 20, 2024 THE HANDLE IS BROKEN. THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT.THIS REPORT IS FOR ONE HANDLE WITH MINI QUICK COUPLING FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18839400 ↗
• MalfunctionJan 19, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRIVER WAS BROKEN AND WAS UNABLE TO BE USED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE HANDLE WITH MINI QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18543378 ↗
• MalfunctionSep 14, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, INSTRUMENT WAS REPORTED FOR REASON NOT SPECIFIED. THIS WAS A PRE OP CASE, SO THERE WAS NO PATIENT INVOLVEMENT. DURING THE SERVICE AND REPAIR EVALUATION IT WAS IDENTIFIED THAT THE INSTRUMENT COULD NOT HOLD THE BIT. THIS REPORT INVOLVES ONE (1) HANDLE WITH MINI QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17745203 ↗
• MalfunctionAug 31, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE RESETTING TRAYS THE SALES REP FOUND ISSUES WITH THE INSTRUMENTS IN QUESTION. THE TIP OF THE DEPTH GAUGE WAS FOUND TO BE BENT, THE QUICK CONNECT SCREWDRIVER WOULD NOT ENGAGE WITH DRIVER SHAFTS, AND THE QUICK CONNECT HANDLE WAS BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A HANDLE WITH MINI QUICK COUPLING. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17663740 ↗