NA 03.110.000Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982071804), received between Apr 9, 2015 and Aug 31, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• MalfunctionAug 31, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE AND MONTH IN 2023, THE TRAYS AND INSTRUMENTS WERE BROKEN. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 1.8MM UNIVERSAL VARIABLE ANGLE LOCKING DRILL GUIDE. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17662968 ↗
• MalfunctionOct 25, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CONE WOULD NOT STICK TO THE PLATE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 1.8MM UNIVERSAL VARIABLE ANGLE LOCKING DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15667172 ↗
• MalfunctionDec 3, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE SHORT T25 SCREWDRIVERS (03.010.513 X2) ARE STRIPPED ON THE TIP AND NO LONGER ENGAGE IN THE SCREW RECESS. ALSO, THE 2.4MM VA-LCP ¿CONE¿ DRILL GUIDE (03.110.000 X1) IS DAMAGED AND WILL NOT ENGAGE IN THE HOLES OF A PLATE. CONCOMITANT DEVICES: UNKNOWN SCREW ( PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN PLATE ( PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 1.8MM UNIVERSAL VARIABLE ANGLE LOCKING DRILL GUIDE. THIS IS REPORT 2 OF 3 FOR (B)(4)..

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9404992 ↗
• MalfunctionJan 10, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON DECEMBER 2, 2018, DURING INVENTORY OF DISTAL RADIUS SET AT SANTA ANA METRO OFFICE IT WAS NOTICED THAT THE UNKNOWN VARIABLE ANGLE DRILL GUIDE WASN'T ALLOWING THE UNKNOWN DRILL BIT TO PASS SMOOTHLY THROUGH THE INSTRUMENT. THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8237413 ↗
• MalfunctionAug 13, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, THE DRILL BIT WOULD NOT FIT THROUGH UNIVERSAL VARIABLE ANGLE (VA) LOCKING DRILL GUIDE. THE SURGEON WENT TO DRILL THROUGH THE NOMINAL ANGLE OF THE DRILL GUIDE BUT WAS NOT SUCCESSFUL DESPITE SWITCHING DRILL BITS. IT APPEARS THE NOMINAL ANGLE PART OF DRILL GUIDE WAS DAMAGED. A DIFFERENT DRILL GUIDE WAS USED. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY NOTED. NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES REPORTED: UNKNOWN DRILL BIT (PART #, UNKNOWN, LOT# UNKNOWN, QUANTITY # UNKNOWN). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7777881 ↗
• MalfunctionJul 27, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON AN (B)(6) 2018, DURING A PREOPERATIVE PHASE (PATIENT AND SURGEON HAD NOT YET ENTERED THE ROOM) FOR AN ANKLE RECONSTRUCTION PROCEDURE, IT WAS NOTICED THAT THE TINES ON A VARIABLE ANGLE DRILL GUIDE WERE DAMAGED AND CAUSED IT TO NOT LOCK CORRECTLY ON THE PLATE. THE DRILL GUIDE WAS PLACED ASIDE AND NOT USED DURING THE PROCEDURE. A BACKUP UNIVERSAL VA LOCKING DRILL GUIDE FROM ANOTHER SET WAS USED TO COMPLETE THE PROCEDURE. THE DAMAGED UNIVERSAL VARIABLE ANGLE (VA) LOCKING DRILL GUIDE AND THE STANDARD 2 COLUMN VOLAR PLATE WERE DISCARDED AFTER THE CASE. THE PROCEDURE WAS COMPLETED WITH NO SURGICAL DELAY. PATIENT OUTCOME WAS STABLE. CONCOMITANT DEVICE: 2.4MM VARIABLE ANGLE LOCKING COMPRESSION PLATE VOLAR RIM DISTAL RADIUS PLATE (PART: UNKNOWN, LOT, UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 1.8MM UNIVERSAL VARIABLE ANGLE LOCKING DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7728499 ↗
• MalfunctionNov 16, 2017Failure to Align; Failure to Align

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE REPORTED DEVICES WERE USED IN THE SURGERY FOR THE RIGHT DISTAL RADIUS FRACTURE ON (B)(6) 2017. AFTER THE DISTAL RADIUS PLATE WAS PLACED, THE PLATE WAS TEMPORARILY FIXED WITH THE K-WIRE. WHEN THE SURGEON TRIED TO INSERT THE LOCKING SCREW TO THE PLATE, IT WAS FOUND THAT THE DRILL GUIDE COULD NOT BE CONNECTED. THE DRILL GUIDE COULD NOT BE CONNECTED TO THE PLATE EITHER IN THE VA MODE OR IN THE FIXED MODE. WHEN THE GUIDE WIRE WAS SOMEHOW CONNECTED TO THE PLATE SLIGHTLY, THE SURGEON STARTED DRILLING. ALTHOUGH THE SURGEON TRIED TO INSERT THE LOCKING SCREW, THE SURGEON WAS UNABLE TO INSERT ALL THE WAY TO THE SCREW HEAD; THUS, THE SURGEON GAVE UP ON INSERTING THE LOCKING SCREW. MOREOVER, THIS LOCKING SCREW WAS USED IN TO OTHER SCREW HOLE OF THE PLATE WITHOUT ANY PROBLEM. THE SURGERY WAS EXTENDED FOR 15 MINUTES BUT COMPLETED SUCCESSFULLY. NO ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED. THE PLATE AND SCREW REMAIN IN PATIENT BODY. CONCOMITANT DEVICES REPORTED: K-WIRE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM-STERILE (PART# 04.210.118S, LOT# UNKNOWN, QU

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7036812 ↗
• MalfunctionAug 14, 2017Break; Break

  IT WAS REPORTED A 1.8 MM UNIVERSAL VARIABLE LOCKING ANGLE DRILL GUIDE WAS FOUND IN PROCESSING, ON (B)(6) 2017, WHEN GOING THROUGH THE SET, THE TIP OF THE CONE WAS BROKEN AND IS MISSING SOME METAL PIECES. THE DRILL GUIDE WAS USED FOR AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RADIUS ON (B)(6) 2017. THERE WERE NO MALFUNCTIONS OR DAMAGES REPORTED WHEN THIS DRILL GUIDE WAS USED DURING THE SURGERY. POST OPERATIVELY, AFTER STERILE NO PATIENT WAS INVOLVED WITH THIS EVENT. THIS COMPLAINT IS FOR ONE (1) DEVICE ONLY. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6792640 ↗
• MalfunctionApr 9, 2015Break

  IT WAS REPORTED THAT A VARIABLE ANGLE LOCKING DRILL GUIDE WAS FOUND TO BE BROKEN AT THE END OF A DISTAL RADIUS OPEN REDUCTION INTERNAL FIXATION SURGERY. UPON INSPECTION, IT WAS NOTED THAT 1 OF THE 4 PEGS WAS BROKEN OFF THE DEVICE. THE DEVICE, HOWEVER, WAS NOT USED DURING THE PROCEDURE AND DID NOT CAUSE ANY ADVERSE EFFECTS TO THE PATIENT. THE DEVICE WAS FOUND TO BE BROKEN IN THE TRAY AFTER SURGERY. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 4674576 ↗