NA 209.940Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982151339), received between Jun 24, 2021 and Jun 24, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, ON AN UNKNOWN PROCEDURE, THE (1) DEPTH GAUGE FOR SMALL SCREWS, (2) PROTECTION SLEEVE/ 11/8, (2) DRILL SLEEVE / 4.2MM, (2) SCREWDRIVER SHAFT SDDRIVE 165MM, (6) 2.8MM FIXED ANGLE DRILL GUIDE, (3) 7.3MM CANNULATED SCREW 32MM THREAD/140MM, (1) SCR RACK 6.5 TI&SS CANN SCRS-16/32 THRDS, (1) LCKNG ATTACH WASHER TRAY RFN-ADVANCED, (2) 2.4 VA 2-CLMN VLR DRP 7H HD/3H SFT/RT-S, (2) 2.4 VA 2-CLMN VLR DRP 7H HD/3H SFT/LT-S HAVE AN UNKNOWN ALLEGATION. FIXED ANGLE GUIDES DON¿T FIT INTO VA LOCKING HOLES, SCREWS WERE STRIPPED IN PROCESS. THERE WAS NO KNOWN HOSPITAL OR PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWENTY-TWO (22) DEVICES. THIS REPORT IS FOR (1) 7.3MM CANNULATED SCREW 32MM THREAD/140MM. THIS REPORT IS 11 OF 13 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12063566 ↗
• MalfunctionJun 24, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, ON AN UNKNOWN PROCEDURE, THE (1) DEPTH GAUGE FOR SMALL SCREWS, (2) PROTECTION SLEEVE/ 11/8, (2) DRILL SLEEVE / 4.2MM, (2) SCREWDRIVER SHAFT SDDRIVE 165MM, (6) 2.8MM FIXED ANGLE DRILL GUIDE, (3) 7.3MM CANNULATED SCREW 32MM THREAD/140MM, (1) SCR RACK 6.5 TI&SS CANN SCRS-16/32 THRDS, (1) LCKNG ATTACH WASHER TRAY RFN-ADVANCED, (2) 2.4 VA 2-CLMN VLR DRP 7H HD/3H SFT/RT-S, AND (2) 2.4 VA 2-CLMN VLR DRP 7H HD/3H SFT/LT-S HAVE AN UNKNOWN ALLEGATION. FIXED ANGLE GUIDES DON'T FIT INTO VA LOCKING HOLES, SCREWS WERE STRIPPED IN PROCESS. THERE WAS NO KNOWN HOSPITAL OR PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWENTY-TWO (22) DEVICES. THIS REPORT IS FOR (1) 7.3MM CANNULATED SCREW 32MM THREAD/140MM. THIS REPORT IS 10 OF 13 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12063565 ↗
• MalfunctionJun 24, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, ON AN UNKNOWN PROCEDURE, THE (1) DEPTH GAUGE FOR SMALL SCREWS, (2) PROTECTION SLEEVE/ 11/8, (2) DRILL SLEEVE / 4.2MM, (2) SCREWDRIVER SHAFT SDDRIVE 165MM, (6) 2.8MM FIXED ANGLE DRILL GUIDE, (3) 7.3MM CANNULATED SCREW 32MM THREAD/140MM, (1) SCR RACK 6.5 TI&SS CANN SCRS-16/32 THRDS, (1) LCKNG ATTACH WASHER TRAY RFN-ADVANCED, (2) 2.4 VA 2-CLMN VLR DRP 7H HD/3H SFT/RT-S, (2) 2.4 VA 2-CLMN VLR DRP 7H HD/3H SFT/LT-S HAVE AN UNKNOWN ALLEGATION. FIXED ANGLE GUIDES DON¿T FIT INTO VA LOCKING HOLES, SCREWS WERE STRIPPED IN PROCESS. THERE WAS NO KNOWN HOSPITAL OR PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWENTY-TWO (22) DEVICES. THIS REPORT IS FOR (1) 7.3MM CANNULATED SCREW 32MM THREAD/140MM. THIS REPORT IS 2 OF 13 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12063351 ↗