NA 03.133.003Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10886982269935), received between Oct 28, 2021 and Sep 18, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829438 ↗
• MalfunctionMay 18, 2026Break

  IT WAS REPORTED THAT THE CABLE TENSIONER WAS NOT WORKING CORRECTLY WHICH MEANT THEY HAD TO CUT THE CABLE OFF THE PLATE AND START AGAIN WITH A DIFFERENT CABLE AND TENSIONER. THE VA DOUBLE DRILL GUIDE ALSO BROKE WHILST THE SURGEON WAS TRYING TO REMOVE THE GUIDE FROM THE PLATE. THIS DELAYED THE OPERATION BUT APPROXIMATELY 15 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25201017 ↗
• MalfunctionApr 28, 2026Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DRILL GUIDE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020978 ↗
• MalfunctionFeb 20, 2026Break

  IT WAS REPORTED THAT THE GUIDE WAS BROKEN AND UNUSABLE. THE UNIT WAS DAMAGED OUT OF THE TRAY. THE UNIT WAS BROKEN DURING THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24403279 ↗
• MalfunctionNov 5, 2025Break; Break

  IT WAS REPORTED THAT THE DRILL GUIDE BROKE DURING AN OPERATION. THE OPERATION WENT WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23480656 ↗
• MalfunctionApr 3, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE VA GUIDE WAS FOUND BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21762210 ↗
• MalfunctionMar 18, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE ITEMS ARE STRIPPED, WON'T CONNECT ON QC. THERE WAS NO PATIENT STATUS CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633678 ↗
• MalfunctionMar 17, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE ITEMS ARE STRIPPED, WON¿T CONNECT ON QC. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21620816 ↗
• MalfunctionFeb 26, 2025Break; Break

  IT WAS REPORTED THAT THE DRILL GUIDE ON THE PPFX ANCILLARY BROKE IN TWO (2) DURING A FEMORAL SYNTHESIS FOR RIGHT PERI-PROSTHETIC FRACTURE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21469136 ↗
• MalfunctionFeb 5, 2025Break; Break

  IT WAS REPORTED THAT THE PLASTIC ON GUIDE BROKE WHILE USING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21315997 ↗
• MalfunctionMay 21, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENT WAS BROKEN WHILE STILL IN ITS PACKAGE. THERE WAS NO HOSPITAL INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE 3.5MM VA DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19364656 ↗
• MalfunctionOct 6, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, ONE END OF THE DRILL GUIDE WAS SNAPPED OFF. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT INVOLVES ONE 3.5MM VA DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR PC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17886107 ↗
• MalfunctionMar 14, 2023Break; Break

  THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FRAGMENTS WERE RETAINED IN THE PATIENTS BODY, AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16539428 ↗
• MalfunctionMar 9, 2023Break; Break

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE VA DRILL GUIDE BROKE DURING USE. SURGERY WAS DELAYED WHILE A REPLACEMENT SET WAS OPENED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 3.5MM VA DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16513578 ↗
• MalfunctionJan 27, 2023Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, THE SURGEON WAS USING 3.5 CONE DRILL GUIDE WHILE DRILLING FOR LOCKING SCREWS IN THE LAW PLATE AND IT SNAPPED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 3.5MM VA DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16258975 ↗
• MalfunctionOct 5, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022 3.5MM VA DRILL GUIDE BROKE DURING SURGERY. NO SURGICAL DELAY WAS THERE. RAD AIMING ARM/FRN GREATER TROCHANTER FOUND MISSING SLEEVE HOLDING TABS, NOT INVOLVES IN SURGERY. PATIENT OUTCOME WAS STABLE. IT WAS UNKNOWN PROCEDURE SUCCESSFULLY COMPLETED OR NOT. THIS REPORT IS FOR ONE (1) 3.5MM VA DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15546563 ↗
• MalfunctionSep 2, 2022Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE 3.5MM VA DRILL GUIDE BROKE WHEN TRYING TO SEAT IT INTO THE VARIABLE ANGLE (VA) LOCKING HOLE OF THE PLATE. THERE WAS NO REPORTED PATIENT CONSEQUENCE. THIS REPORT IS FOR A 3.5MM VA DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15348909 ↗
• MalfunctionNov 30, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE GUIDEWIRE (ZIMMER) THAT WAS INSIDE THE UNIVERSAL CHUCK, WOULD NOT OPEN. IT APPEARS 'FROZEN' AND WILL NOT UNLOCK. THE 3.5MM VA DRILL GUIDE BROKE AFTER THE SURGEON WAS TRYING TO ENGAGE THE CONE SIDE INTO THE LOCKING ATTACHMENT WASHER (LAW) PLATE. NO FRAGMENTS WERE GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: RFNA / 11 / 420 5 DEG BEND / STERILE (PART#: 04.233.142S, LOT#: UNKNOWN, QUANTITY: 1). LCKNG ATTACH WASHER RFNA / 5 DEG/ RT/ S (PART#: 02.233.100S, LOT#: UNKNOWN, QUANTITY: 1). UNIVERSAL CHUCK (PART#: 03.043.001, LOT#: UNKNOWN, QUANTITY: 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 3.5MM VA DRILL GUIDE THIS IS REPORT 1 OF 11 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12897093 ↗
• MalfunctionOct 28, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, UPON ROUTINE INSPECTION, THE DRILL GUIDE IS BROKEN OFF AT THE 2.8MM SIDE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.5MM VA DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712884 ↗