NA 219124Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10886705005420), received between Jul 2, 2013 and Sep 15, 2026 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Break” (32 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Break; Illegible Information

  It was reported that the tip of the SCR/WASH HEXDRV 2.5MM device broke into the S&W CORT 56MM screw device. It was reported that there was a 2-minute delay due to the event. It was reported that it was unknown if the event occurred during a surgical procedure. There were no adverse consequences to the patient. No additional information could be provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50772066 ↗
• MalfunctionJan 22, 2026Break

  IT WAS REPORTED THAT DURING A MEDIAL COLLATERAL LIGAMENT (MCL) RECONSTRUCTION PROCEDURE IT WAS OBSERVED THAT THE SCR/WASH HEXDRV 2.5MM DEVICE WAS BROKEN. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24146360 ↗
• MalfunctionAug 21, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE SCR/WASH HEXDRV DEVICE BROKE OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22865692 ↗
• MalfunctionJun 12, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE, THE TIP OF THE SCR/WASH HEXDRV 2.5MM DEVICE BROKE OFF. ACCORDING TO THE REPORTER, THERE WAS A SYSTEM OR BACKUP FIXATION ON THE TIBIA. AFTER DRILLING AND INSERTING THE SCREW, THE TIP OF A TWO-AND-A-HALF MILLIMETER HEX DRIVER BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS DELAYED, THOUGH THE EXACT DURATION OF THE DELAY WAS NOT SPECIFIED. IT WAS NOT REPORTED WHETHER A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22195217 ↗
• MalfunctionJan 22, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE HEAD ON THE SCREW DEVICE BROKE OFF INTO THE SCREW WHILE INSERTING THE LAST WASHER. ACCORDING TO THE REPORT, THEY WERE ABLE TO RETRIEVE THE BROKEN SCREW. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552227 ↗
• MalfunctionJul 11, 2023Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE HEAD ON THE 2.5MM DRIVER DEVICE BROKE OFF WHILE A SCREW WAS BEING TIGHTENED. THE PROCEDURE WAS COMPLETED AS IT WAS WHILE ALL PIECES OF THE BROKEN HEAD OF HEX WERE RETRIEVED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES X (X) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17300173 ↗
• MalfunctionDec 15, 2022Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE OF THE TIBIA, IT WAS OBSERVED THAT THE DRIVER - FOR USE WITH MITEK CORTICAL & CANCELLOUS SCREWS HAD PHYSICAL DAMAGE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE TIP ON THE DEVICE WAS BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15988632 ↗
• MalfunctionAug 4, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE TIP OF THE DRIVER DEVICE BROKE WHEN SITTING THE SCREW ON THE TIBIA. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15165346 ↗
• MalfunctionMar 25, 2022Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING A POSTERIOR LATERAL CORNER RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE TIP ON THE SCR/WASH HEXDRV 2.5MM SCREWDRIVER DEVICE BROKE OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13903575 ↗
• MalfunctionDec 14, 2021Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE TIP ON THE SCR/WASH HEXDRV 2.5MM DEVICE BROKE UPON INSERTION TO THE SOFT TISSUE AT THE END OF THE CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13003382 ↗
• MalfunctionJan 29, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE SCR/WASH HEXDRV 2.5MM *EA DEVICE BROKE OFF IN THE PATIENT. ALL FRAGMENTS GENERATED WERE RETRIEVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11253147 ↗
• MalfunctionOct 30, 2020Break; Break

  THIS COMPLAINT HAS BEEN CREATED IN ORDER TO DOCUMENT THE BLIND DEVICE RECEIVED WITH PRODUCT CODE #: UNK -DRIVER / LOT/SERIAL #:UNKNOWN. NO INFORMATION IS AVAILABLE REGARDING THE PATIENT DETAILS OR HCP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10760310 ↗
• MalfunctionSep 16, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE THE TIP OF THE DRIVER BROKE AT THE END OF THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10542834 ↗
• MalfunctionAug 11, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE THE TIP OF THE DRIVER - FOR USE WITH MITEK CORTICAL & CANCELLOUS SCREWS BROKE OFF WHILE PUTTING IN THE SCREW. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THEY RETRIEVED THE DRIVER TIP WITHOUT PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10391856 ↗
• MalfunctionJul 17, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN UNKNOWN PROCEDURE THE TIP OF THE SCR/WASH HEXDRV 2.5MM *EA SNAPPED OF. ALL FRAGMENTS WERE RETRIEVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10290322 ↗
• MalfunctionMay 21, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA COMPLAINT SUBMISSION TOOL THE SCR/WASH HEXDRV 2.5MM *EA. SCREW DRIVER TIP BROKE WHEN PUTTING IN SCREW. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10080675 ↗
• MalfunctionNov 4, 2019Break; Break

  IT WAS REPORTED DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) PROCEDURE ON (B)(6) 2019, THE MICRO TORNADO HANDPIECE WITH HAND CONTROLS TURNED WARMER THAN NORMAL AND WOULD NOT POWER OFF. THERE WAS A FLASHING LIGHT WITH BEEPS BUT NO POWER. THEY WERE ABLE TO COMPLETE THE CASE WITH ANOTHER LIKE DEVICE WITH A 3 MINUTE DELAY TO GET ANOTHER HAND PIECE. ADDITIONALLY, THE SCREWDRIVER TIP BROKE OFF WHILE TIGHTENING A SCREW. THEY RETRIEVED THE TIP WITH NO PATIENT HARM OR DELAY AND FINISHED THE CASE WITH ANOTHER LIKE DEVICE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9272608 ↗
• MalfunctionAug 13, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE THE TIP OF THE CUSTOMER'S SCR / WASH HEX DRIVER 2.5 MM BROKE OFF IN THE SCREW. THE SALES REP STATED THAT THE BROKEN TIP WAS EASILY REMOVED FROM THE SCREW WITHOUT ANY FURTHER ISSUES AND THAT THERE WAS NO DEBRIS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE DEVICE AS THE DEVICE AND BROKEN TIP WERE DISCARDED BY THE CUSTOMER. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8888461 ↗
• MalfunctionJun 3, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA CST THAT DURING AN ACL RECONSTRUCTION PROCEDURE, IT WAS OBSERVED THAT THE DRIVER TIP BROKE WHILE INSERTING THE SCREW. IT WAS REPORTED THAT THE TIP WAS ONLY FRAGMENT THAT BROKE AND WAS EASILY REMOVED. THE CASE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DRIVER. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8663459 ↗
• MalfunctionFeb 19, 2019Break; Break

  THE SALES REP REPORTED THAT PRIOR TO UNKNOWN PROCEDURE ON AN UNKNOWN DATE DURING STERILIZATION THE TIP OF THREE OF THEIR SCREW/WASH HEX DRIVERS 2.5MM BROKE OFF. THE SALES REP STATED THAT THE DEVICES BROKE PRIOR TO BEING USED ON THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP COULD NOT PROVIDE LOT NUMBERS FOR THESE DEVICES. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. THE DEVICES WILL BE RETURNING FOR EVALUATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8352118 ↗
• MalfunctionFeb 19, 2019Break; Break

  THE SALES REP REPORTED THAT PRIOR TO UNKNOWN PROCEDURE ON AN UNKNOWN DATE DURING STERILIZATION THE TIP OF THREE OF THEIR SCREW/WASH HEX DRIVERS 2.5MM BROKE OFF. THE SALES REP STATED THAT THE DEVICES BROKE PRIOR TO BEING USED ON THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP COULD NOT PROVIDE LOT NUMBERS FOR THESE DEVICES. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. THE DEVICES WILL BE RETURNING FOR EVALUATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8352095 ↗
• MalfunctionFeb 19, 2019Break; Break

  THE SALES REP REPORTED THAT PRIOR TO UNKNOWN PROCEDURE ON AN UNKNOWN DATE DURING STERILIZATION THE TIP OF THREE OF THEIR SCREW/WASH HEX DRIVERS 2.5MM BROKE OFF. THE SALES REP STATED THAT THE DEVICES BROKE PRIOR TO BEING USED ON THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP COULD NOT PROVIDE LOT NUMBERS FOR THESE DEVICES. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. THE DEVICES WILL BE RETURNING FOR EVALUATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8352044 ↗
• MalfunctionJan 4, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA EMAIL AND PHONE THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CUSTOMER'S SCREW/WASHER DRIVER TIP BROKE WHILE INSERTING A SCREW INTO THE PATIENT. THE SALES REP STATED THAT THE TIP WAS REMOVED FROM THE PATIENT WITH NO DEBRIS LEFT BEHIND. THE CASE WAS COMPLETED WITH ANOTHER LIKE-DEVICE WITH NO PATIENT HARM OR DELAY. THE SALES REP COULD NOT PROVIDE A LOT NUMBER. THE DEVICE WAS DISCARDED BY THE CUSTOMER. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8219309 ↗
• MalfunctionOct 9, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A KNEE SURGERY PROCEDURE, IT WAS OBSERVED THAT THE SCREW WASHER HEX DRIVER TIP BROKE WHILE PUTTING IN THE SCREW. THE SALES REP STATED THAT NO FRAGMENTS WERE CREATED. THE SALES REP STATED THAT THERE WERE NO PROCEDURAL OR ANATOMICAL FACTORS THAT CONTRIBUTED TO BREAKAGE. THE CASE WAS COMPLETED WITH ANOTHER LIKE-DEVICE WITH NO PATIENT HARM OR DELAYS. THE SALES REP WAS NOT PRESENT FOR THE CASE AND COULD NOT PROVIDE ANY ADDITIONAL INFORMATION. THE SALES REP WAS UNABLE TO PROVIDE A LOT NUMBER. THE DEVICE IS BEING RETURNED FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7947289 ↗
• MalfunctionAug 11, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMERS DRIVER, THE SCREW TIGHTENED AND THE JAW BROKE (THE PART THAT INSERTS INTO THE SCREW HEAD). THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITH ANOTHER LIKE DEVICE, WITH NO DELAY AND NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7775531 ↗