NA 03.130.125Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982075284), received between Jul 1, 2019 and Mar 10, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Material Deformation

  IT WAS REPORTED DURING THE PROCEDURE, IT WAS NOTED THE END OF THE DRILL GUIDE WAS BENT. THE DRILLING WAS PERFORMED FREEHAND WITHOUT USING THE DRILL GUIDE. THE PROCEDURE AS COMPLETED SUCCESSFULLY WITH NO DELAY OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560754 ↗
• MalfunctionOct 15, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THE 1.0/1.3 DRILL GUIDE 1.0 END TIP BENT. THE DRILL BIT WAS NOT ABLE TO GO THROUGH DRILL GUIDE, AND THE 1.0 DRILL BIT SNAPPED AT THE TIP WHEN PRESSURE APPLIED. TWO NEW DRILL BITS FROM DRILL BIT CADDY WERE USED, WITH BOTH BREAKING. SURGICAL DELAY OF 5 MINUTES. PROCEDURE COMPLETED SUCCESSFULLY. A NEW DRILL BIT OPENED. WHEN 2ND ONE SNAPPED, DRILL GUIDE WAS NOT USED. FRAGMENTS WERE GENERATED BUT RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23293635 ↗
• MalfunctionJul 2, 2025Break; Break

  IT WAS REPORTED THAT THE 1.3/1.0 DBLE DRILL SLV 1.3 CRTX SCRS/YEL FROM THE VA HAND WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22385959 ↗
• MalfunctionJan 15, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THESE ITEMS WERE NOT WORKING PROPERLY. DRILL GUIDES AND T6 POWER SHAFT WERE BENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21162390 ↗
• MalfunctionMar 15, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PREOPERATIVELY ON AN UNKNOWN DATE IN (B)(6) 2023, THE DRILL GUIDE WAS BENT. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 1.3/1.0MM DOUBLE DRILL SLEEVE FOR 1.3MM CRTX SCREWS/YELLOW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16545305 ↗
• MalfunctionJan 10, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF LOANER SET IT WAS OBSERVED THAT THE DOUBLE DRILL SLEEVE WAS BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9576547 ↗
• MalfunctionDec 10, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THE UNKNOWN WIRE WAS STUCK IN GUIDE/DOUBLE DRILL SLEEVE. COMPLETED THE PROCEDURE WITH BACK UP DEVICE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS 1 OF 2 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9444401 ↗
• MalfunctionSep 9, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DOUBLE DRILL SLEEVE (GUIDE) CAME TO STERILE PROCESSING WITH THE TIP ON THE 1.0 MM SIDE BENT. THE 1.0 MM SIDE OF THE DRILL GUIDE IS BENT NOT ALLOWING THE DRILL BIT TO SLIDE SMOOTHLY THROUGH THE GUIDE. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNK - DRILL BITS: TRAUMA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS IS REPORT 1 FOR 1 (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8977053 ↗
• MalfunctionJul 1, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON AN UNKNOWN DATE, DURING A ROUTINE INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE DOUBLE DRILL SLEEVE WAS BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 1.3/1.0 MM DOUBLE DRILL SLEEVE FOR 1.3 MM CRTX SCREWS/YELLOW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8749177 ↗