NA 03.127.006Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982075062), received between Nov 1, 2019 and Nov 13, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE GUIDE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547738 ↗
• MalfunctionJan 17, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6)2025 WHILE INSPECTING THE INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS SALES REP NOTICED THAT THERE WERE SEVERAL INSTRUMENTS THAT WERE DAMAGED. 1. PRODUCT # 511.744, LOT # UNKNOWN, QUANTITY (B)(4) THIS PIECE WAS DAMAGED BASED UPON THE SCREWDRIVER TIP, NOT BEING ABLE TO BE PUT INTO THE TORQUE LIMITER. THE LOT NUMBER IS UNKNOWN FOR THIS ITEM SINCE IT WAS DISCARDED BY THE FACILITY. 2. PRODUCT # 03.900.360, LOT # UNKNOWN, QUANTITY (B)(4) THESE THREE ITEMS ARE T 15 SCREWDRIVERS, AND THE TIPS OF THE SCREWDRIVERS WERE STRIPPED AND UNABLE TO HOLD A SCREW ON IT. A LOT NUMBERS FOR THESE ITEMS ARE UNKNOWN SINCE THEY WERE ALL THREE DISCARDED BY THE FACILITY. 3. PRODUCT # 03.127.002, LOT # UNKNOWN, QUANTITY (B)(4) THIS ITEM WAS A DRILL CONE FOR A VARIABLE ANGLE PLATE, AND THE CONE TIP WAS BENT, AND IS UNABLE TO BE LOCKED INTO A PLATE. THE LOT NUMBER FOR THIS DEVICE IS UNKNOWN SINCE THE ITEM WAS DISCARDED BY THE FACILITY. 4. PRODUCT # 03.127.006, LOT # UNKNOWN, QUANTITY (B)(4) THIS ITEM IS A VARIABLE ANGLE GUIDE, AND THE TIP OF THE ANGLE GUIDE HAS BEEN SMASHED, AND THE DRILL IS UNABLE TO PASS THROUGH IT. THE LOT NUMBER ON THIS DEVICE IS UNKNOWN SINCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21179001 ↗
• MalfunctionDec 12, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE HANDLE OF THE INSTRUMENT IN QUESTION BROKE OFF. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A PROTECTION SLEEVE FOR 2.8MM VA DRILL GUIDE ¿ LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18313487 ↗
• MalfunctionOct 19, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING PROXIMAL TIBIA ORIF, THE PROTECTION SLEEVE BROKE IN HALF DURING USE. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) PROTECT SLEEVE F/VA DRILL GUIDE 3.5 F/DR THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17965881 ↗
• MalfunctionJul 7, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2023, THE DRILL GUIDE BROKE AT THE HANDLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE PROTECTION SLEEVE FOR 2.8MM VA DRILL GUIDE - LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17278552 ↗
• MalfunctionNov 4, 2021Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT FOR A PROCEDURE. IT WAS NOTED THAT THE DRILL GUIDE HANDLE WAS BROKEN. THERE WAS NO SURGICAL DELAY AND NO FRAGMENT GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES NOTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) PROTECTION SLEEVE FOR 2.8MM VA DRILL GUIDE - LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12751396 ↗
• MalfunctionOct 25, 2021Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE IN (B)(6) 2021 THAT THE PROTECTION GUIDE WAS POORLY WELDED. WHEN USED IN SURGERY IT EASILY DE-SOLDERED. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. THIS REPORT IS FOR ONE (1) PROTECTION SLEEVE FOR 2.8MM VA DRILL GUIDE - LONG. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12693148 ↗
• MalfunctionJan 12, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020 THE HANDLE OF PROTECTION SLEEVE FOR 2.8 MM VARIABLE ANGLE DRILL GUIDE LONG WAS BROKEN AND WAS SEPARATED FROM THE TUBE PORTION. IT WAS FOUND IN THE STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT. THIS REPORT IS FOR 1 PROTECTION SLEEVE FOR 2.8MM VA DRILL GUIDE - LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11156938 ↗
• MalfunctionAug 24, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PROTECTION SLEEVE FOR DRILL GUIDE WAS BROKEN IN THE FIELD. AND AS CONFIRMED BY THE REPORTER, IT WAS FOUND BROKEN WHEN THEY OPENED THE SET. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT INVOLVES ONE (1) PROTECTION SLEEVE FOR 2.8MM VA DRILL GUIDE - LONG. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10445103 ↗
• MalfunctionFeb 11, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PROTECTION SLEEVE FOR 2.8MM VA DRILL GUIDE LONG WAS DISCOVERED BENT WHILE RESTOCKING. WHILE TRYING TO BEND IT BACK, THE HANDLE BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) PROTECTION SLEEVE FOR 2.8MM VA DRILL GUIDE - LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9694439 ↗
• MalfunctionNov 1, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, A PROTECTION SLEEVE WAS BENT WHEN IT WAS PUTTING THE SET BACK TOGETHER. THE SALES CONSULTANT ATTEMPTED TO UNBEND IT AND IT BROKE. 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 9268134 ↗