Drill Sleeve Guide DSG-6.3-090-2.4NRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00841823106520), received between Jan 6, 2020 and Feb 14, 2020 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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. 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 14, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  AN AD-TECH CLINICAL SPECIALIST OBSERVED A CASE IN WHICH A BIT AND GUIDE (WHICH WERE TESTED FOR FIT PRIOR TO USE BY THE USER AND WERE ACCEPTABLE) FUSED. THEY WERE ABLE TO SWAP OUT THE GUIDE FOR THEIR BACKUP, USE IRRIGATION, AND WERE ABLE TO COMPLETE THE REMAINING TRAJECTORIES WITHOUT ANY ADDITIONAL FUSING. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9713577 ↗
• MalfunctionFeb 14, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2018, A DISTRIBUTOR ATTENDED A SEEG CASE ON WHICH THE FIRST TRAJECTORY THE DRILL SLEEVE GUIDE AND DRILL BIT FUSED. THEY HAD A BACKUP AND SWITCHED THE TOOLS OUT WITH A NEW KIT WHICH ALSO FUSED. THOSE COMPONENTS WERE SEPARATED AND LUBRICATED WITH MINERAL OIL AND NO ADDITIONAL PROBLEMS OCCURRED. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9713337 ↗
• MalfunctionFeb 14, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  AT A CASE ATTENDED BY AD-TECH CLINICAL SPECIALISTS THE DRILL BIT FUSED WITH THE GUIDE ON THE 4TH TRAJECTORY. THERE WAS NO PATIENT HARM AND THE CASE PROCEEDED WITH ANOTHER DRILL KIT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9713011 ↗
• MalfunctionFeb 13, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  ON JULY 17, 2018, AN AD-TECH EMPLOYEE RECEIVED A REPORT THAT A DRILL BIT FUSED TO THE DRILL SLEEVE GUIDE. NO INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9707190 ↗
• MalfunctionFeb 13, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  ON JUNE 29, 2018, AN AD-TECH CLINICAL SPECIALIST RECEIVED A REPORT THAT THE DRILL FUSED IN THE GUIDE. THERE WAS NO INJURY REPORTED. THE PRODUCT WILL NOT BE RETURNED AS IT WAS DISPOSED OF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9707140 ↗
• MalfunctionFeb 13, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(4) 2018, AN AD-TECH CLINICAL SPECIALIST RECEIVED A PHONE CALL REPORTING THAT A DRILL SLEEVE GUIDE FUSED WITH THE DRILL BIT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9706405 ↗
• MalfunctionFeb 13, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2018, AN AD-TECH CLINICAL SPECIALIST RECEIVED AND EMAIL FROM A CUSTOMER STATING THAT DURING THE PREVIOUS DAY'S CASE, THE DRILL SLEEVE GUIDE GOT JAMMED. THEY WERE UNABLE TO REMOVE THE DRILL FROM THE DRILL GUIDE. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9706208 ↗
• MalfunctionFeb 13, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  A USER FACILITY REPORTED THAT THE DRILL BIT FUSED WITH THE DRILL SLEEVE GUIDE DESPITE LUBRICATION WITH MEDICAL GRADE MINERAL OIL. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9706095 ↗
• MalfunctionFeb 13, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  AN AD-TECH CLINICAL SPECIALIST ATTENDING A CASE REPORTED THAT WHEN THE PHYSICIAN WAS DRILLING THROUGH THE FIRST TRAJECTORY, OUR DRILL BIT FUSED WITH THE DRILL SLEEVE GUIDE. THEY FINISHED THE CASE WITH ANOTHER DRILL BIT AND AN ALTERNATIVE GUIDE WITH NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9706018 ↗
• MalfunctionFeb 13, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  A PHYSICIAN REPORTED THAT DURING A RECENT SEEG CASE THE DRILL FUSED WITH THE GUIDE WHILE DRILLING THE 7TH TRAJECTORY. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9705973 ↗
• MalfunctionFeb 13, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  AN AD-TECH CLINICAL SPECIALIST ATTENDING A CASE AT A USER FACILITY REPORTED THAT THE DRILL BIT SEIZED IN THE DRILL SLEEVE GUIDE, POSSIBLY DUE TO OVERTIGHTENING THE DRILL STOP, BENDING THE BIT. THE SECOND BIT WAS USED AND THE CASE PROCEEDED WITHOUT PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9705921 ↗
• MalfunctionFeb 5, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  AN AD-TECH FOREIGN DISTRIBUTOR REPORTED TO AD-TECH THAT DURING AN SEEG PLACEMENT USING THE CRW FRAME AND AD-TECH DRILL BITS AND GUIDE, A PHYSICIAN REPORTED THAT THE DRILL FUSED WITH THE GUIDE WHILE DRILLING. THERE WAS NO REPORTED IMPACT TO PATIENT SAFETY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9673631 ↗
• MalfunctionFeb 5, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2018 A USER FACILITY REPORTED ISSUES WITH AN AD-TECH DRILL BIT AND SLEEVE GUIDE IN AN SEEG CASE THEY HAD THAT DAY. THE DRILL SLEEVE BLOCKS WERE FUSED TO THE DRILL SLEEVE GUIDE. THE CUSTOMER USED A BACKUP AND THE CASE PROCEEDED AS PLANNED WITHOUT ANY OTHER ISSUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9673579 ↗
• MalfunctionJan 6, 2020Mechanical Jam; Mechanical Jam

  CUSTOMER ENCOUNTERED DRILL BIT FUSING TO THE DRILL SLEEVE GUIDE ON THE 4TH HOLE. THEY HAD A BACKUP AND SUCCESSFULLY PLACED THE DEPTH ELECTRODE. THE PATIENT WAS NOT AFFECTED BY THE INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9553414 ↗