NA 03.211.002Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982076007), received between Apr 17, 2018 and Oct 22, 2024 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT STATUS WAS STABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506607 ↗
• MalfunctionNov 14, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THERE WAS A DAMAGED DRILL SLEEVE FROM A HAND/FOOT SET. A DRILL BIT BECAME JAMMED IN THE SLEEVE AND BROKE DURING A PROCEDURE. THE HOSPITAL WERE UNABLE TO REMOVE THE DRILL BIT AND DISPOSED OF BOTH IN A SHARPS BIN. THERE WAS NO PATIENT HARM, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 2.0MM UNIVERSAL VARIABLE ANGLE LOCKING DRILL GUIDE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15788618 ↗
• MalfunctionNov 10, 2022Break; Break

  AT THE TIME OF DRILLING, THE 2.0 DRILL BIT BROKE, AND THE BROKEN TIP WAS RECOVERED; THE AV GUIDE SHOWED THAT ONE OF THE ENDS OF THE CONE WAS BROKEN AT THE TIME OF DRILLING. THE DOCTOR WAS NOTIFIED, AND A RADIOLOGICAL SEARCH WAS MADE. THERE WAS NO EVIDENCE THAT IT WAS FOUND IN THE OPERATIVE FIELD. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15776254 ↗
• MalfunctionMay 7, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, ONE OF THE PRONGS ON THE VARIABLE ANGLE SIDE OF THE GUIDE IS BROKEN OFF. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS COMPLAINT INVOLVES ONE(1) DEVICE 2.0 UNIV VARIABLE ANG LACKING DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14316724 ↗
• MalfunctionAug 18, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, SURGEON STATES THE VA DRILL GUIDES AND DEPTH GAUGES FROM THE STANDARD VA SYSTEMS ARE NOT USER FRIENDLY AND DUE TO THEIR DIFFICULTY OF USE HE HAS HAD DELAYS FOR MISPLACED SCREWS. THE VA DRILL GUIDE IS TOO DIFFICULT TO LOCK INTO THE SMALL 2.7MM HOLES RESULTING IN OCCASIONAL OVER ANGLES OF DRILLS. THE DEPTH GAUGES FOUND ON THE SYSTEMS ARE ALSO DIFFICULT TO READ AS THE MEASUREMENTS ONLY APPEAR ON ONE SIDE OF THE INSTRUMENT. THE NEW STYLE 2.7MM DRILL GUIDES AND DEPTH GAUGES ARE REQUIRED TO ENSURE CORRECT SCREW PLACEMENT IN THE SMALL VA PLATES. AS NOT ALL SURGEONS IN THE ACCOUNT HAVE THIS DIFFICULTY I WOULD LIKE TO KEEP THE OLD STYLE INSTRUMENTS AND THE NEW STYLE INSTRUMENTS TO GIVE ALL SURGEONS THE INSTRUMENTS THEY FIND WORK BEST. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 2.0MM UNIVERSAL VARIABLE ANGLE LOCKING DRILL GUIDE. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12340057 ↗
• MalfunctionAug 18, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, SURGEON STATES THE VA DRILL GUIDES AND DEPTH GAUGES FROM THE STANDARD VA SYSTEMS ARE NOT USER FRIENDLY AND DUE TO THEIR DIFFICULTY OF USE HE HAS HAD DELAYS FOR MISPLACED SCREWS. THE VA DRILL GUIDE IS TOO DIFFICULT TO LOCK INTO THE SMALL 2.7MM HOLES RESULTING IN OCCASIONAL OVER ANGLES OF DRILLS. THE DEPTH GAUGES FOUND ON THE SYSTEMS ARE ALSO DIFFICULT TO READ AS THE MEASUREMENTS ONLY APPEAR ON ONE SIDE OF THE INSTRUMENT. THE NEW STYLE 2.7MM DRILL GUIDES AND DEPTH GAUGES ARE REQUIRED TO ENSURE CORRECT SCREW PLACEMENT IN THE SMALL VA PLATES. AS NOT ALL SURGEONS IN THE ACCOUNT HAVE THIS DIFFICULTY I WOULD LIKE TO KEEP THE OLD STYLE INSTRUMENTS AND THE NEW STYLE INSTRUMENTS TO GIVE ALL SURGEONS THE INSTRUMENTS THEY FIND WORK BEST. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR (1) 2.0MM UNIVERSAL VARIABLE ANGLE LOCKING DRILL GUIDE. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12340056 ↗
• MalfunctionAug 18, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, SURGEON STATES THE VA DRILL GUIDES AND DEPTH GAUGES FROM THE STANDARD VA SYSTEMS ARE NOT USER FRIENDLY AND DUE TO THEIR DIFFICULTY OF USE HE HAS HAD DELAYS FOR MISPLACED SCREWS. THE VA DRILL GUIDE IS TOO DIFFICULT TO LOCK INTO THE SMALL 2.7MM HOLES RESULTING IN OCCASIONAL OVER ANGLES OF DRILLS. THE DEPTH GAUGES FOUND ON THE SYSTEMS ARE ALSO DIFFICULT TO READ AS THE MEASUREMENTS ONLY APPEAR ON ONE SIDE OF THE INSTRUMENT. THE NEW STYLE 2.7MM DRILL GUIDES AND DEPTH GAUGES ARE REQUIRED TO ENSURE CORRECT SCREW PLACEMENT IN THE SMALL VA PLATES. AS NOT ALL SURGEONS IN THE ACCOUNT HAVE THIS DIFFICULTY I WOULD LIKE TO KEEP THE OLD STYLE INSTRUMENTS AND THE NEW STYLE INSTRUMENTS TO GIVE ALL SURGEONS THE INSTRUMENTS THEY FIND WORK BEST. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR (1) 2.0MM UNIVERSAL VARIABLE ANGLE LOCKING DRILL GUIDE. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12340053 ↗
• MalfunctionAug 18, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, SURGEON STATES THE VA DRILL GUIDES AND DEPTH GAUGES FROM THE STANDARD VA SYSTEMS ARE NOT USER FRIENDLY AND DUE TO THEIR DIFFICULTY OF USE HE HAS HAD DELAYS FOR MISPLACED SCREWS. THE VA DRILL GUIDE IS TOO DIFFICULT TO LOCK INTO THE SMALL 2.7MM HOLES RESULTING IN OCCASIONAL OVER ANGLES OF DRILLS. THE DEPTH GAUGES FOUND ON THE SYSTEMS ARE ALSO DIFFICULT TO READ AS THE MEASUREMENTS ONLY APPEAR ON ONE SIDE OF THE INSTRUMENT. THE NEW STYLE 2.7MM DRILL GUIDES AND DEPTH GAUGES ARE REQUIRED TO ENSURE CORRECT SCREW PLACEMENT IN THE SMALL VA PLATES. AS NOT ALL SURGEONS IN THE ACCOUNT HAVE THIS DIFFICULTY I WOULD LIKE TO KEEP THE OLD STYLE INSTRUMENTS AND THE NEW STYLE INSTRUMENTS TO GIVE ALL SURGEONS THE INSTRUMENTS THEY FIND WORK BEST. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR (1) 2.0MM UNIVERSAL VARIABLE ANGLE LOCKING DRILL GUIDE. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12340052 ↗
• MalfunctionMar 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR THE DISTAL HUMERAL AND ELBOW FRACTURES WITH THE PLATE AND SCREWS. A VA DRILL SLEEVE WAS USED TO DRILL FROM THE SUPPORT OF THE POSTEROLATERAL PLATE. AT THAT TIME, THE DRILL SLEEVE CAME OFF A LITTLE, BUT IT WAS DRILLED. THEN, A VA LOCKING SCREW WAS INSERTED. THE SCREW WAS NOT TORQUED AND WAS IDLING WITHOUT LOCKING. THE SURGEON COMMENTED THAT THE DRILL SLEEVE CAME OFF WHILE DRILLING AND HE COULD NOT DRILL PROPERLY, AND IT CAUSED THIS EVENT. WHEN VISUALLY CHECKED, THE SCREW TIP CAME OUT OF THE BONE, SO THE SURGEON REMOVED THE SCREW, AND A SHORTER 34 MM SCREW WAS INSERTED, BUT IT WOULD NOT LOCK. WHEN THE SURGEON CHECKED AGAIN, THE TIP OF THE SCREW WAS OUT OF THE BONE. THE SURGEON DRILLED AGAIN AND INSERTED 36 MM SCREW. THE SAME EVENT OCCURRED, AND A 20 MM SCREW WAS FINALLY INSERTED. THIS 20 MM SCREW DID NOT LOCK, BUT THE INCISION WAS CLOSED AT THE SURGEON¿S DISCRETION AND THE 20 MM SCREW REMAINED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH THIRTY (30) MINUTE DELAY. THIS REPORT INVOLVES ONE (1) 2.0MM UNIVERSAL VARIA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11485435 ↗
• MalfunctionNov 25, 2020Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICES REPORTED: DRILL BIT (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), VA PLATE (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), LOCKING SCREWS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10904973 ↗
• MalfunctionAug 13, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING ELBOW SURGERY ONE OF THE TEETH ON THE 2.0 MM UNIVERSAL VARIABLE ANGLE LOCKING GUIDE FOR THE 2.7 MM LOCKING SCREWS BROKE DURING THE PROCEDURE. THE METAL PIECE WAS RETRIEVED AND THE PROCEDURE CONTINUED. FRAGMENTS WERE GENERATED FROM A BROKEN DEVICE AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO SURGICAL DELAY REPORTED. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY# UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8888738 ↗
• InjuryApr 17, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) FOR A LEFT DISTAL HUMERAL FRACTURE ON (B)(6) 2018. DURING THE PROCEDURE, THE DRILL GUIDE WAS NOT PROPERLY FITTED TO THE PLATE. THE SURGEON DRILLED THE SCREW HOLE AND INSERTED THE VARIABLE ANGLE (VA) LOCKING SCREW. WHEN THE SURGEON ATTEMPTED TO REMOVE THE SCREW FOR REPLACEMENT, IT JUST SPUN IN THE HOLE AND COULD NOT BE REMOVED. SURGEON CUT OFF THE SCREW HEAD IN ORDER TO REMOVE THE SCREW. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 15 MINUTES. PATIENT BLED A LITTLE DUE TO THIS EVENT BUT IS REPORTED AS STABLE. SURGEON STATED DRILLING IN THE INCOMPLETE THREAD ENGAGEMENT MAY HAVE DAMAGED THE SCREW HOLE AND INSERTION OF THE SCREW AT AN ANGLE GREATER THAN 15 DEGREES MAY HAVE DAMAGED THE LOCKING MECHANISM OF THE PLATE. CONCOMITANT DEVICE REPORTED: PLATE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1) THIS REPORT IS FOR ONE (1) 2.0MM UNIVERSAL VARIABLE ANGLE LOCKING DRILL GUIDE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Blood Loss

  MAUDE report 7437562 ↗