Disposable Drill Kit DDK2-2.4-30XRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00841823101167), received between Apr 6, 2017 and Jun 9, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (10 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 18, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2026

  TIP OF THE DRILL BROKE BROKE DURING INTRAOPERATIVE USE AND REMAINS RETAINED IN THE PATIENT, THE BROKEN PIECE COULD NOT BE RETRIEVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25443126 ↗
• MalfunctionJan 2, 2024Material Fragmentation; Material Fragmentation

  ON 12/20/2023 IT WAS COMMUNICATED BY EMAIL THAT DURING A DEPTH ELECTRODE IMPLANTATION ON (B)(6) 2023, A DRILL KIT TIP SHEARED OFF INTO THE TEMPORALIS MUSCLE OF THE PATIENT. THE PATIENT NEEDED AN INTRAOPERTAIVE X-RAY TO VISUALIZE AND LOCALIZE THE DRILL BIT TO FACILITATE REMOVAL.THE TIP WAS RECEIVED USING FLUOROSCOPY AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18428418 ↗
• MalfunctionSep 30, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  ON (B)(6) 2022, AD-TECH MEDICAL RECEIVED THE (B)(6) 2022 REPORT FROM DISTRIBUTOR, NIHON KOHDEN REPORTING THAT ONE DDK2-2.4-30X HAD A HOLE IN THE POUCH. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15509422 ↗
• MalfunctionMay 6, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  DURING AN SEEG DEPTH CASE USING A ROSA GUIDE, THE DRILL BIT FUSED WITH THE GUIDE WHILE DRILLING. THE GUIDE AND DRILL BIT WERE ABLE TO BE SEPARATED AND THE CASE PROCEEDED USING BACK UPS WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14309525 ↗
• MalfunctionMay 6, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  DURING AN SEEG DEPTH CASE USING A FHC GUIDE, THE DRILL BIT FUSED WITH THE GUIDE WHILE DRILLING. THE GUIDE AND DRILL BIT WERE REPLACED WITH NEW AND THE CASE PROCEEDED AS PLANNED WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14309470 ↗
• MalfunctionMay 6, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  DURING AN SEEG DEPTH CASE USING A ROSA GUIDE, THE DRILL BITS FUSED WITH THE GUIDE WHILE DRILLING. THE GUIDE AND DRILL BITS WERE ABLE TO BE SEPARATED AND THE CASE PROCEEDED AS PLANNED WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14309203 ↗
• MalfunctionMay 6, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  DURING AN SEEG DEPTH CASE USING A ROSA GUIDE, THE DRILL BIT FUSED WITH THE GUIDE WHILE DRILLING. THE GUIDE AND DRILL BIT WERE ABLE TO BE SEPARATED AND THE CASE PROCEEDED AS PLANNED WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14307011 ↗
• MalfunctionJun 21, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  DURING AN SEEG DEPTH CASE USING A ROSA GUIDE, THE DRILL BIT FUSED WITH THE GUIDE WHILE DRILLING. THE GUIDE AND DRILL BIT WERE ABLE TO BE SEPARATED. A NEW DRILL BIT WAS USED AND THE CASE PROCEEDED AS PLANNED WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12036943 ↗
• MalfunctionDec 22, 2020Break

  ON (B)(6) 2020, AD-TECH MEDICAL WAS NOTIFIED THAT A DRILL BIT BROKE DURING PLACEMENT OF THE LAST ELECTRODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11056308 ↗
• MalfunctionAug 5, 2020Break

  ON JULY 6, 2020, AD-TECH MEDICAL WAS NOTIFIED THAT A DRILL BIT SNAPPED IN HALF WHILE DRILLING, DURING AN SEEG CASE USING A ROSA ROBOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10370547 ↗
• MalfunctionFeb 19, 2020Break; Break

  ON (B)(6) 2018, AN AD-TECH CLINICAL SPECIALIST ATTENDED A CASE WHERE THE DOCTOR EXPERIENCED AN ISSUE WITH A BROKEN DRILL BIT. ACCORDING TO THE CLINICAL SPECIALIST, IT WAS STATED THAT THE DOCTOR WAS DRILLING INTO THE PATIENT'S SKULL AND HALFWAY THROUGH, THE DRILL BIT SNAPPED OFF. THERE WAS NO KNOWN IMPACT TO PATIENT SAFETY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9729114 ↗
• MalfunctionFeb 19, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ON (B)(6) 2018 AD-TECH RECEIVED A COMPLAINT FROM A CUSTOMER STATING THAT WHEN DRILLING THROUGH THE ROSA GUIDE ON THE FIRST TRAJECTORY THE DRILL BIT SNAPPED AND FUSED TO THE GUIDE. THEY WERE ABLE TO USE A REPLACEMENT GUIDE AND DRILL BIT TO FINISH THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9727137 ↗
• MalfunctionFeb 14, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ON 11/8/2017 AN AD-TECH CLINICAL SPECIALIST ATTENDING A SURGICAL CASE OBSERVED THAT THE DRILL BIT FUSED WITH THE DRILL SLEEVE GUIDE AND BROKE. THE SURGERY WAS ABLE TO BE FINISHED USING ALTERNATIVE EQUIPMENT AND THERE WAS NO REPORTED INJURY TO THE PATIENT.

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

  MAUDE report 9712651 ↗
• MalfunctionFeb 14, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  A USER FACILITY REPORTED THAT THE DRILL BIT SEIZED IN THE DRILL SLEEVE GUIDE, POSSIBLY DUE TO IMPROPER HANDLING BY THE USER FACILITY. BACK UP TOOLS WERE USED AND THE CASE PROCEEDED WITHOUT PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9711519 ↗
• MalfunctionFeb 14, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ON 5/1/2017 IT WAS REPORTED THAT A DRILL BIT WAS STUCK INSIDE A REDUCING TUBE AND STUCK INSIDE CRW BLOCK PIECE, NO HARM TO THE PATIENT WAS REPORTED.

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

  MAUDE report 9710924 ↗
• MalfunctionFeb 13, 2020Mechanical Problem; Mechanical Problem

  ON (B)(6) 2019 AD-TECH RECEIVED A COMPLAINT FROM A USER FACILITY REGARDING THE FUSING OF AN AD-TECH DRILL BIT TO A ROSA GUIDE DURING A SEEG PROCEDURE. THE PROCEDURE COULD NOT PROCEED AND WAS SUBSEQUENTLY RESCHEDULED FOR THE FOLLOWING DAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9707293 ↗
• MalfunctionFeb 13, 2020Smoking; Smoking

  AN AD-TECH CLINICAL SPECIALIST ATTENDING A CASE AT A USER FACILITY REPORTED THAT A DRILL BIT BEGAN SMOKING DURING USE. THEY SWITCHED TO ANOTHER DRILL AND CONTINUED THE CASE SUCCESSFULLY. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9705842 ↗
• MalfunctionFeb 12, 2020Inaccurate Information; Inaccurate Information

  ON (B)(6) 2017 A CUSTOMER INFORMED US THAT UPON OPENING A BOX OF DRILL BITS THE ACTUAL PRODUCT IN THE BOX WAS A DIFFERENT SIZE DRILL BIT. THEY HAD ADDITIONAL DRILL BITS ON THE SHELF AND PROCEEDED THE CASE AS SCHEDULED WITHOUT INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9701836 ↗
• MalfunctionFeb 5, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2019, AN AD-TECH CLINICAL SPECIALIST WAS NOTIFIED ABOUT AN ISSUE THAT OCCURRED WHEN AD-TECH'S DRILL BIT LOCKED INTO THE GUIDE. THE CASE PROCEEDED WITH A BACKUP DRILL AND THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9673789 ↗
• MalfunctionJan 29, 2020Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  ON APRIL 17, 2018, AD-TECH RECEIVED A REPORT FROM A USER FACILITY THAT PRODUCT WAS FOUND WITH COMPROMISED STERILE BARRIER. THE PRODUCT WAS DISCARDED AND THERE WAS NO IMPACT TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9644909 ↗
• MalfunctionOct 31, 2019Material Fragmentation; Material Fragmentation

  ON DECEMBER 1, 2019, AD-TECH RECEIVED A COMPLAINT THAT TWO DRILL BITS BROKE DURING SURGERY WHILE ATTEMPTING AN OBLIQUE ANGLE WITH A ROSA. BOTH BITS WERE RETRIEVED AND THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9263201 ↗
• MalfunctionAug 2, 2017Break; Break

  ON JUNE 5, 2017, AD-TECH MEDICAL RECEIVED AN EMAIL FROM A CUSTOMER STATING THAT "DURING DRILLING THIS BIT BROKE AND WAS LODGED DEEP TO THE SKULL". AD-TECH RESPONDED BACK TO THE CUSTOMER THAT DAY TO OBTAIN ADDITIONAL INFORMATION TO HELP AID WITH THE COMPLAINT INVESTIGATION. TO DATE, THE CUSTOMER HAS NOT RESPONDED BACK. IT IS UNKNOWN WHAT THE OUTCOME OR CURRENT STATUS IS OF THE PATIENT. A SUPPLEMENT REPORT WILL BE INITIATED SHOULD AD-TECH RECEIVE ADDITIONAL INFORMATION RELEVANT TO THIS MEDWATCH REPORT.

  Patient problems: No Information

  MAUDE report 6761983 ↗
• MalfunctionApr 6, 2017Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  ON (B)(6) 2017, DURING A CASE AT A CUSTOMER SITE, THE AD-TECH CLINICAL SPECIALIST WITNESSED A COMPROMISED STERILE BARRIER OF THE PACKAGING FOR ONE OF AD-TECH'S STERILE DRILL BITS. SPECIFICALLY, WHEN THE CUSTOMER OPENED THE BOX AND RETRIEVED THE FIRST DRILL BIT POUCH, A SMALL, PIN-SIZED HOLE WAS FOUND ON THE TYVEK SIDE OF THE OUTER POUCH, AS WELL AS THE TYVEK SIDE OF THE INNER POUCH. THE HOLES WERE IDENTIFED WHERE THE TIP OF THE DRILL BIT MEETS THE POUCHES. AD-TECH'S DISPOSABLE DRILL KITS CONTAIN 2 SEPARATELY PACKAGED DRILL BITS PER KIT. THERE WAS NO KNOWN PATIENT IMPACT AND NO DELAY IN SURGERY. THE OTHER DRILL BIT WAS NOT COMPROMISED AND WAS USED FOR THE CASE. THE IMPACTED DRILL BIT WAS SENT BACK TO AD-TECH FOR INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6465561 ↗