NA 02.211.060Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982053817), received between May 25, 2018 and Nov 23, 2021 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 23, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE, WHEN ATTEMPTING TO INSERT A 2.7 VA LOCKING SCREW, THE SURGEON WAS UNABLE TO GET THE SCREW ENGAGE INTO THE PLATE. THE LOCKING SCREW WAS ACCEPTED, AND MORE SCREWS WERE PUT IN AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES NOTED. THIS REPORT INVOLVES ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 60MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12863306 ↗
• MalfunctionSep 7, 2021Break; Break

  IT WAS REPORTED ON (B)(6) 2021, WHILE INSERTING A 2.7MM VA LOCKING SCREW INTO A 2.7MM VA OLECRANON PLATE, METAL SHAVINGS WERE CREATED BETWEEN THE SCREW AND THE LOCKING HOLES. FRAGMENTS WERE GENERATED AND WAS REMOVED WITHOUT ANY ADDITIONAL INTERVENTION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNK - SCREWDRIVER: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 60MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12435487 ↗
• MalfunctionSep 3, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON THAT (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE VA LOCKING SCREW WOULD NOT LOCK INTO PLATE HOLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES TWO(2) DEVICES. THIS REPORT IS FOR (1) 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 60. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12421635 ↗
• InjuryOct 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: IT WAS REPORTED ON (B)(6) 2020, THAT PATIENT UNDERWENT REVISION SURGERY DUE TO NONUNION AND 1 BROKEN 60MM LENGTH VA LOCKING SCREW. ONE (1) VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) EXTENDED MEDIAL DISTAL HUMERUS PLATE, SEVEN (7) VA LOCKING SCREWS AND ONE (1) CORTEX SCREW AND ONE (1) VA LCP DISTAL HUMERUS PLATE WERE SUCCESSFULLY EXPLANTED. THERE WAS A FRAGMENT OF THE SHAFT AND THE SCREWHEAD BUT IT WAS REMOVED EASILY WITHOUT ADDED TIME. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES.

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10755504 ↗
• InjuryOct 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: IT WAS REPORTED ON (B)(6) 2020, THAT PATIENT UNDERWENT REVISION SURGERY DUE TO NONUNION AND 1 BROKEN 60MM LENGTH VA LOCKING SCREW. ONE (1) VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) EXTENDED MEDIAL DISTAL HUMERUS PLATE, SEVEN (7) VA LOCKING SCREWS AND ONE (1) CORTEX SCREW AND ONE (1) VA LCP DISTAL HUMERUS PLATE WERE SUCCESSFULLY EXPLANTED. THERE WAS A FRAGMENT OF THE SHAFT AND THE SCREWHEAD BUT IT WAS REMOVED EASILY WITHOUT ADDED TIME. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES.

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10755228 ↗
• MalfunctionOct 23, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING OPEN REDUCTION AND INTERNAL FIXATION OF PROXIMAL ULNA THE VARIABLE ANGLE LOCKING SCREW WOULD NOT LOCK INTO THE THIRD MOST PROXIMAL HOLE OF VARIABLE-ANGLE LOCKING COMPRESSION PLATE (VA-LCP) PROXIMAL OLECRANON. THE SURGEON LEFT BOTH IMPLANTS IN THE PATIENT. THERE WAS A TWO (2) MINUTES SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. PATIENT WAS GOOD. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10729091 ↗
• InjuryJan 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT HAD UNDERGONE AN ORTHOPEDIC REMOVAL PROCEDURE DUE TO PAIN. ORIGINAL DATE OF IMPLANT WAS ON (B)(6) 2012 FOR AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE LEFT ELBOW. IT WAS NOTED THAT FRACTURE HAD ALREADY HEALED. DEVICES INVOLVED WERE ONE (1) 3.5 MM CORTEX SCREW 16MM, ONE (1) 3.5MM CORTEX SCREW 20MM, ONE (1) 3.5 MM CORTEX SCREW 24MM, ONE (1) 3.5MM CORTEX SCREW 26MM, ONE (1) VARIABLE ANGLE (VA)-LOCKING COMPRESSION PLATE (LCP) EXTENDED MEDIAL DISTAL HUMERUS PLATE, ONE (1) METAPHYSEAL SCREW, ONE (1) 2.7MM VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 50MM, TWO (2) 2.7MM VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 60MM, ONE (1) LCP POSTEROLATERAL DISTAL HEMERUS PLATE WITH LATERAL SUPPORT, ONE (1) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14MM, TWO (2) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 16MM, ONE (1) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 20MM, AND ONE (1) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 60MM. ALL IMPLANTS WERE REMOVED EXCEPT FOR FOUR (4) SCREWS AS THE HEADS OF THE SCREWS WERE BROKEN OFF. IT WAS NOT DETERMINED WHICH AMONG THE SCREWS WERE

  Patient problems: Pain

  MAUDE report 8245322 ↗
• InjuryJan 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT HAD UNDERGONE AN ORTHOPEDIC REMOVAL PROCEDURE DUE TO PAIN. ORIGINAL DATE OF IMPLANT WAS ON (B)(6) 2012 FOR AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE LEFT ELBOW. IT WAS NOTED THAT FRACTURE HAD ALREADY HEALED. DEVICES INVOLVED WERE ONE (1) 3.5 MM CORTEX SCREW 16MM, ONE (1) 3.5MM CORTEX SCREW 20MM, ONE (1) 3.5 MM CORTEX SCREW 24MM, ONE (1) 3.5MM CORTEX SCREW 26MM, ONE (1) VARIABLE ANGLE (VA)-LOCKING COMPRESSION PLATE (LCP) EXTENDED MEDIAL DISTAL HUMERUS PLATE, ONE (1) METAPHYSEAL SCREW, ONE (1) 2.7MM VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 50MM, TWO (2) 2.7MM VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 60MM, ONE (1) LCP POSTEROLATERAL DISTAL HUMERUS PLATE WITH LATERAL SUPPORT, ONE (1) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14MM, TWO (2) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 16MM, ONE (1) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 20MM, AND ONE (1) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 60MM. ALL IMPLANTS WERE REMOVED EXCEPT FOR FOUR (4) SCREWS AS THE HEADS OF THE SCREWS WERE BROKEN OFF. IT WAS NOT DETERMINED WHICH AMONG THE SCREWS WERE

  Patient problems: Pain

  MAUDE report 8245295 ↗
• InjuryDec 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT NOT ALL THE DEVICES WERE REMOVED. IT IS UNKNOWN WHICH SPECIFIC DEVICES WERE REMOVED.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 8128368 ↗
• MalfunctionMay 29, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A RIGHT OLECRANON ON (B)(6) 2018. THE SURGEON USED THE UNIVERSAL VARIABLE ANGLE (VA) LOCKING DRILL GUIDE AT THE MAXIMUM AMOUNT OF ANGULATION (15 DEGREES OFF CENTER ACCESS) TO INSERT A (VA) LOCKING SCREW INTO THE MOST PROXIMAL HOLE OF THE VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) OLECRANON PLATE. WHILE DRILLING THE SCREW UNDER POWER WITH THE DRILL BIT, FLAKES OR SHARDS FROM THE SCREW FLEW OUTSIDE OF THE PATIENT. THE (VA) LOCKING SCREW WAS REMOVED AND REPLACED WITH ANOTHER (VA) LOCKING SCREW. THE SAME PLATE REMAINED IN THE PATIENT. THE ISSUE APPEARS TO RESIDE WITH THE DRILL GUIDE. WHEN THE ALLOTTED MAXIMUM ANGULATION WAS REACHED, THE THREADING OF THE SCREW BEGAN TO STRIP OFF FROM THE THREADING OF THE PLATE. THE SCREW THREADS SEEMED TO STRIP WHEN THE ANGULATION FROM THE DRILL GUIDE WAS TOO WIDE. THE SCREW WAS DISCARDED BY THE HOSPITAL. THERE ARE TWO DRILL GUIDES AT THE HOSPITAL. IT IS UNKNOWN WHICH DRILL GUIDE WAS USED FOR THE PROCEDURE. THERE WAS A SURGICAL DELAY OF APPROXIMATELY ONE (1) MINUTE TO REMOVE AND REPLACE THE SCREW. ROUTINE INTRAOPERATIVE X-RAYS WERE TAKEN AS A STANDARD FOR THE P

  Patient problems: No Code Available

  MAUDE report 7549313 ↗
• MalfunctionMay 25, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A RIGHT OLECRANON ON (B)(6) 2018. THE SURGEON USED THE UNIVERSAL VARIABLE ANGLE (VA) LOCKING DRILL GUIDE AT THE MAXIMUM AMOUNT OF ANGULATION (15 DEGREES OFF CENTER ACCESS) TO INSERT A (VA) LOCKING SCREW INTO THE MOST PROXIMAL HOLE OF THE VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) OLECRANON PLATE. WHILE DRILLING THE SCREW UNDER POWER WITH THE DRILL BIT, FLAKES OR SHARDS FROM THE SCREW FLEW OUTSIDE OF THE PATIENT. THE (VA) LOCKING SCREW WAS REMOVED AND REPLACED WITH ANOTHER (VA) LOCKING SCREW. THE SAME PLATE REMAINED IN THE PATIENT. WHEN THE ALLOTTED MAXIMUM ANGULATION WAS REACHED, THE THREADING OF THE SCREW BEGAN TO STRIP OFF FROM THE THREADING OF THE PLATE. THE SCREW THREADS SEEMED TO STRIP WHEN THE ANGULATION FROM THE DRILL GUIDE WAS TOO WIDE. THE SCREW WAS DISCARDED BY THE HOSPITAL. THERE ARE TWO DRILL GUIDES AT THE HOSPITAL. IT IS UNKNOWN WHICH DRILL GUIDE WAS USED FOR THE PROCEDURE. THERE WAS A SURGICAL DELAY OF APPROXIMATELY ONE (1) MINUTE TO REMOVE AND REPLACE THE SCREW. ROUTINE INTRAOPERATIVE X-RAYS WERE TAKEN AS A STANDARD FOR THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7545616 ↗