NA 03.133.007Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982269966), received between Aug 18, 2021 and Nov 11, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. THE DAY BEFORE THE SURGERY, THE PRODUCTS IN QUESTION WERE CLEANED BEFORE STERILIZATION. JUST BEFORE THE STERILIZATION, A STAFF FROM THE CENTRAL STERILE SUPPLY DEPARTMENT FOUND THAT THE PAINT (BLACK AND ORANGE) ON THE PRODUCTS IN QUESTION WAS PEELING OFF. BECAUSE THE PAINT PEELED OFF EASILY WHEN THE PRODUCTS WERE TOUCHED, THE REPLACEMENTS WERE ARRANGED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23524404 ↗
• MalfunctionOct 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORIF WITH DHP FOR THE DISTAL HUMERUS. DOUBLE PLATING AT 90-DEGREE ANGLE WAS PERFORMED. THE SCREW IN QUESTION WAS INSERTED INTO THE MOST DISTAL SCREW HOLE OF THE INTERNAL PLATE. ALL THE SCREWS WERE INSERTED INTO THE REQUIRED SCREW HOLES. FLEXION AND EXTENSION OF THE ELBOW JOINT SHOWED LIMITED EXTENSION WHILE CHECKING THE IMAGE BEFORE CLOSURE. IT WAS FOUND THAT THE SCREW IN QUESTION THAT WAS HAVING DIFFICULTY CONNECTING THE DRILL SLEEVE BEHAVED THE SAME WAY. WHEN THE SURGEON TRIED TO REMOVE THE SCREW, IT WAS BROKEN OFF AT THE SCREW HEAD AND THE SCREW SHAFT REMAINED IN THE BONE. DRILLING WAS PERFORMED AGAIN, AND A NEW SCREW WAS INSERTED PROPERLY. THE SURGEON CONFIRMED WITH THE IMAGE THAT THERE WAS NO BROKEN SCREW, AND THE WOUND WAS CLOSED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. SINCE THIS WAS A DIFFICULT AREA TO CONNECT THE DRILL SLEEVES, THE SURGEON AND SENIOR PHYSICIAN GUESSED THAT A TECHNICAL ERROR CAUSED THE SCREW TO BE INSERTED IN THE INCORRECT POSTERIOR DIRECTION, WHICH WAS OUTSIDE THE BONE AND INTERFERED WITH THE OLECRANON DURING EXTENSION, CAUSING IT TO BREAK. THE DRILL SLEEVES USED FOR C

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

  MAUDE report 20506712 ↗
• MalfunctionOct 18, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE DRILL BIT WAS STUCK IN THE DRILL GUIDE. THERE WAS NO PATIENT OUTCOME. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20481183 ↗
• MalfunctionOct 2, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION (ORIF) SURGERY FOR DISTAL HUMERUS FRACTURE WITH VA-LCP PLATE, VA LOCKING SCREW AND VA SLEEVE. THE SURGEON WANTED TO PLACE THE VA-LCP PLATE USING A MORTAR-SHAPED VA SLEEVE BUT GAVE UP BECAUSE THE ORIENTATION DID NOT MATCH. THEREFORE, THE SURGEON USED THE OPPOSITE SIDE OF THE MORTAR-SHAPED VA SLEEVE TO PERFORM THE DRILLING. THEN, THE VA LOCKING SCREW WAS INSERTED, BUT IT DID NOT LOCK AND IDLED. IN ADDITION, THE OTHER SCREWS USED THE MORTAR-SHAPED SLEEVES AND WERE ABLE TO LOCK WITHOUT PROBLEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VA DRILL GUIDE 2.7.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20351587 ↗
• MalfunctionSep 4, 2024Crack; Material Twisted/Bent; Crack; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024, THE LONG TIP WAS TWISTED AND DAMAGED. THE END OF THE PIECE WAS CRACKED; THEREFORE, IT WAS NOT IN ITS NORMAL SHAPE. THIS WAS DISCOVERED POST-OPERATIVELY. UPON DEVICE RETURN TO THE MANUFACTURER, IT WAS NOTED THAT THE SPHERICAL SLEEVE WAS DEFORMED AND CRACKED FROM THE TIP. THIS REPORT IS FOR A 2.7MM VA DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20135735 ↗
• MalfunctionAug 14, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN OSTEOSYNTHESIS PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, THE DRILL GUIDE BROKE. NO FRAGMENTS WERE GENERATED. A NEW INSTRUMENT WAS USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIVE-MINUTE DELAY. THIS REPORT IS FOR A 2.7MM VA DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19985046 ↗
• MalfunctionJun 4, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024 THE INSTRUMENT FRACTURED INTO TWO OR MORE PARTS INTRAOPERATIVELY. THERE WAS NO PATIENT HARM. THERE WAS A SURGICAL DELAY OF ABOUT FIVE (5) MINUTES SINCE ANOTHER SET OF INSTRUMENTS NEEDED TO BE USED IN ORDER TO COMPLETE THE PROCEDURE. THIS REPORT IS FOR ONE (1) 2.7MM VA DRILL GUIDE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19463372 ↗
• MalfunctionApr 10, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A TRANSCONDYLAR FRACTURE OF THE DISTAL HUMERUS. AFTER IMPLANTING A POSTERIOR LATERAL PLATE, THE SURGEON BEGAN IMPLANTING THE MEDIAL PLATE, BUT THREE SCREWS IDLED AND NO TORQUE COULD BE APPLIED. THE FIRST SCREW WAS INSERTED AFTER DRILLING USING A 2.7 VA DRILL GUIDE, BUT THE SCREW IDLED WHEN THE HEAD CAME NEAR TO THE PLATE. THIS SCREW WAS REMOVED BECAUSE A METAL FRAGMENT WAS GENERATED. THE SECOND SCREW WAS INSERTED INTO THE SAME HOLE AS THE FIRST, BUT IT ALSO IDLED. TORQUE COULD BE LIGHTLY APPLIED TO THIS SCREW SO IT WAS LEFT IN THE HOLE. THE THIRD SCREW WAS INSERTED INTO ANOTHER HOLE AFTER DRILLING WITH THE VA DRILL GUIDE, BUT NO TORQUE COULD BE APPLIED. THIS SCREW WAS ALSO LEFT IN THE HOLE. ANOTHER DRILL GUIDE WAS USED AND THE ISSUES WITH SCREW IDLING AND LACK OF TORQUE WERE RESOLVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT, IT WAS CONFIRMED VIA X-RAY THAT NO FRAGMENTS REMAINED WITHIN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM VA DRILL GUIDE. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19080473 ↗
• MalfunctionOct 30, 2023Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING LOAN KIT INSPECTION THE LOAN KIT TECHNICIAN NOTICED THE PRODUCT IS DAMAGED. THIS REPORT INVOLVES ONE (1) 2.7MM VA DRILL GUIDE. THIS IS REPORT 2 OF 2 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18029368 ↗
• MalfunctionApr 6, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWEDEN AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE PRODUCT GOT BROKEN, IT WAS FOUND BROKEN APART IN THE DISHWASHER. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) VA DRILL GUIDE 2.7 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16692207 ↗
• MalfunctionMar 21, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE INSTRUMENTS IN QUESTION WERE FOUND TO BE BROKEN. THE INSTRUMENTS WERE DISCOVERED AFTER SURGERY. NO PATIENT INVOLVEMENT WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM VA DRILL GUIDE. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16586770 ↗
• MalfunctionOct 13, 2022Break; Break

  IT WAS REPORTED DURING INSPECTION PRE-OP ON (B)(6)2022 , DRILL GUIDE APPEARED BROKEN AND DID NOT SEAT INTO PLATE. CONCOMITANT DEVICE REPORTED: UNK PLATES: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1) THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15594752 ↗
• MalfunctionApr 18, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 3 OF 4 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN OPEN REDUCTION INTERNAL FIXATION SURGERY FOR HUMERAL CONDYLE FRACTURE SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT AN UNKNOWN LOCKING SCREW DEVICE DID NOT LOCK INTO THE FIXATION PLATE DEVICE AFTER DRILLING WITH A THREADED GUIDE DEVICE (03.133.008). ACCORDING TO THE REPORT, THE SURGEON REMOVED THE SCREW TO CHECK THE DIRECTION AND REINSERTED IT BUT STILL DID NOT LOCK. IT WAS REPORTED THAT THE SURGEON USED DRILL GUIDE DEVICE (03.133.007), AND EVEN THOUGH HE CHANGED DIRECTION AND DRILLED, HE COULD NOT LOCK IT TO THE PLATE. IT WAS REPORTED THAT THE EVENT OCCURRED IN BOTH THE 2ND AND 3RD HOLES FROM THE DISTAL END, SO THE SURGEON TRIED OTHER SCREW HOLES AND THEY WERE ABLE TO LOCK WITHOUT PROBLEMS. ANOTHER FIXATION PLATE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH 30 MINUTES OF DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) VA DRILL GUIDE 2.7 DEVICE. THIS COMPLAINT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14137159 ↗
• 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 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12340051 ↗