NA 323.46Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982190857), received between Jul 31, 2018 and Dec 2, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (9 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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 4.5 UNIVERSAL DRILL GUIDES SPRINGS WERE BROKEN UPON CLEANING IN DECONTAMINATION IN CSPD. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693572 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 4.5 UNIVERSAL DRILL GUIDES SPRINGS WERE BROKEN UPON CLEANING IN DECONTAMINATION IN CSPD. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693561 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 4.5 UNIVERSAL DRILL GUIDES SPRINGS WERE BROKEN UPON CLEANING IN DECONTAMINATION IN CSPD. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693534 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 4.5 UNIVERSAL DRILL GUIDES SPRINGS WERE BROKEN UPON CLEANING IN DECONTAMINATION IN CSPD. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693487 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 4.5 UNIVERSAL DRILL GUIDES SPRINGS WERE BROKEN UPON CLEANING IN DECONTAMINATION IN CSPD. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693474 ↗
• MalfunctionMay 29, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRILL GUIDE WAS BENT AND THE TIP WAS SMASHED. DRILL BIT WOULD NOT PASS THROUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22103842 ↗
• MalfunctionJul 8, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENTS WERE BROKEN. IT IS UNKNOWN IF THERE WAS PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 4.5MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 5 OF 8 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED IN (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19694227 ↗
• MalfunctionDec 30, 2021Material Deformation; Material Deformation

  THIS REPORT IS 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13122363 ↗
• MalfunctionApr 5, 2021Break; Break

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION OF A LOANER SET IT WAS OBSERVED THAT THE UNIVERSAL DRILL GUIDE WAS BROKEN AT FSL UPS LYNDHURST, NJ SITE. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 4.5MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11613511 ↗
• MalfunctionDec 9, 2019Break; Break

  IT WAS REPORTED THAT IN THE STERILE PROCESSING DEPARTMENT, A UNIVERSAL DRILL GUIDE AND A T25 STARDRIVE SCREWDRIVER SHAFT WERE NOTED TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9437897 ↗
• MalfunctionOct 8, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING THE INVENTORY OF THE PERIARTICULAR SET, THE TIP OF THE UNIVERSAL DRILL GUIDE WAS OBSERVED TO BE FLARED OUT AND WILL NOT ALLOW THE INSTRUMENT TO BE TAKEN APART FOR CLEANING PURPOSES. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) 4.5MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9168586 ↗
• MalfunctionJun 5, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A ROUTINE INCOMING INSPECTION ON (B)(6) 2019, IT WAS OBSERVED THAT THE UNIVERSAL DRILL GUIDE HAD A STUCK SCREW. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8670068 ↗
• MalfunctionNov 7, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT IN THE STERILE PROCESSING DEPARTMENT ON (B)(6) 2018, IT WAS NOTICED THAT A UNIVERSAL DRILL GUIDE SEEMED TIGHT AND HARD TO GET THE CAP OFF. THERE IS NO PROCEDURE AND PATIENT INVOLVEMENT. THIS REPORT IS FOR A 4.5MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8046010 ↗
• MalfunctionJul 31, 2018Break; Break

  (B)(6) REPORTS THAT ON AN UNKNOWN DATE, THE SPRING OF A UNIVERSAL DRILL GUIDE WAS NOTED TO BE BROKEN AND JAMMED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A 4.5MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7736101 ↗