NA 02.211.040Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982053718), received between Dec 1, 2017 and Mar 11, 2024 — classified as 8 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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.

• MalfunctionMar 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS FURTHER REPORTED NO ADDITIONAL FRAGMENTS WERE CREATED.

  Patient problems: Insufficient Information

  MAUDE report 18876911 ↗
• MalfunctionMar 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS FURTHER REPORTED NO ADDITIONAL FRAGMENTS WERE CREATED.

  Patient problems: Insufficient Information

  MAUDE report 18876892 ↗
• InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT THE DEVICES IN 2016. THE PATIENT FOUND OUT THAT THERE WAS A PROBLEM WITH THE IMPLANTS APPROXIMATELY 2 MONTHS AGO WHEN HE WENT TO THE EMERGENCY ROOM BECAUSE HIS ARM WAS BAD, AND X-RAYS WERE TAKEN. THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE HARDWARE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 40MM. THIS IS REPORT 7 OF 8 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16113696 ↗
• MalfunctionMay 20, 2021Device-Device Incompatibility; Migration; Device-Device Incompatibility; Migration

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE A 2.0MM HOLE WAS DRILLED THROUGH THE MIDDLE SCREW HOLE IN THE HEAD OF THE PLATE USING THE VARIABLE ANGLE DRILL GUIDE. A 2.7MM VARIABLE ANGLE (VA) LOCKING SCREW WAS USED WITH A 1.2NM TORQUE LIMITING ATTACHMENT (TLA) AND A T8 STARDRIVE SCREWDRIVER BIT LOADED ON POWER. THE SCREW WAS POWERED UNTIL THE 1.2NM TLA ENGAGED. ON THE X-RAY THE SCREW HOLE IN THE PLATE WAS OPEN. TAKING A LATERAL X-RAY, THE SCREW COULD BE VIEWED APPROXIMATELY 2-3 MM BEYOND THE PLATE IN THE BONE AND SLIGHTLY POSTERIOR TO THE SCREW HOLE IN THE PLATE. IT DID NOT PROTRUDE THROUGH THE POSTERIOR CORTEX, IT WAS COMPLETELY IN BONE. USING A HAND T8 SCREWDRIVER IT WAS ATTEMPTED TO REMOVE THE SCREW, BUT THE SCREW HEAD COULD NOT BE ENGAGED WITH THE T8 STARDRIVE HEAD. THE SCREW REMAINED IN THE BONE. THE ANGLE THROUGH THE PLATE WAS SLIGHTLY OFF THE NOMINAL AXIS BUT NOT GREATER THAN 15 DEGREES, AS IT APPEARED ON XRAY. THERE WAS A FIVE (5) MINUTE SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES: UNKNOWN DRILL (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). UNKNOWN VA DRILL GUIDE (PAR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11856214 ↗
• InjuryOct 2, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2020, A HARDWARE REMOVAL WAS PERFORMED DUE TO PAIN. ONE (1) 2.7 MM VARIABLE ANGLE LOCKING SCREW 40MM WAS FOUND BROKEN DURING THE REVISION SURGERY. THIS WAS NOT KNOWN PRIOR TO THE SURGERY. ALL HARDWARE WAS COMPLETELY REMOVED EXCEPT THE 2.7 MM VARIABLE ANGLE LOCKING SCREW 4MM. THE HEAD OF THE SCREW WAS REMOVED BUT THE SHAFT OF IT REMAINED IN THE PATIENT. THE ORIGINAL IMPLANTATION DATE WAS UNKNOWN. THERE WAS A SURGICAL DELAY OF ONE (1) MINUTE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 40MM THIS IS REPORT 1 OF 10 FOR (B)(4). THIS COMPLAINT INVOLVES TOTAL 23 DEVICES. (B)(4) REPORTS 10 DEVICES, ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available; Pain

  MAUDE report 10620146 ↗
• MalfunctionSep 18, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE THE THREE (3) LOCKING SCREWS WOULD NOT LOCK INTO THE VARIABLE ANGLE DISTAL HUMERUS PLATE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY 1). THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10553519 ↗
• InjuryAug 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO LEFT ELBOW MONTEGGIA FRACTURE DISLOCATION WITH ULNAR NONUNION, STATUS POST BONE GRAFTING WITH NOW PAINFUL DEEP HARDWARE, POSSIBLE DELAYED UNION, AS WELL AS ULNAR NERVE COMPRESSION. ON (B)(6) 2017, THE PATIENT UNDERWENT A SURGERY AND WAS DIAGNOSED WITH NONUNION LEFT PROXIMAL ULNA STATUS POST OPEN REDUCTION INTERNAL FIXATION MONTEGGIA FRACTURE SUBLUXATION AND WAS IMPLANTED WITH A SYNTHES PLATE AND SCREWS. CONCOMITANT DEVICES REPORTED: 2.7MM/3.5MM VA-LCP OLECRANON PL 4H/LT/116MM (PART NUMBER 02.107.304, LOT UNKNOWN, QUANTITY 1), 2.7MM METAPHYSEAL SCR SLF-TPNG W/T8 STRDRV RECESS/28MM (PART NUMBER 02.118.528, LOT UNKNOWN, QUANTITY 1), 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM (PART NUMBER 02.211.024, LOT UNKNOWN, QUANTITY 1), 2.7MM VA LCK SCREW SLF-TAP (PART NUMBER 02.211.036, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 40MM. THIS IS REPORT 5 OF 5 FOR (B)(4). THIS PRODUCT COMPLAINT, (B)(4), CAPTURES THE REMAINING FIVE (5) OUT OF FIFTEEN (15) DEVICES. (B)(4) CAPTURES THE FIRST TEN (10) DEVICES OF THE THIRD REVISION. (B)(4

  Patient problems: Bone Fracture(s); Nerve Damage; No Code Available; Pain

  MAUDE report 10441969 ↗
• MalfunctionOct 11, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN ORTHOPEDIC PROCEDURE, THREE (3) VARIABLE ANGLE (VA) LOCKING SCREWS WOULD NOT LOCK INTO FOUR DIFFERENT SCREW HOLES OF THE VA LOCKING COMPRESSION PLATE (LCP) OLECRANON PLATE. THERE WAS A SURGICAL DELAY OF 30 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) 2.7MM VA LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 40MM. THIS IS REPORT 2 OF 4 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9181122 ↗
• InjuryJun 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2015, THE PATIENT UNDERWENT A REMOVAL PROCEDURE OF PAINFUL HARDWARE PROXIMAL ASPECT OF RIGHT ULNA. ON (B)(6) 2014, THE PATIENT SUSTAINED AN INJURY AFTER TRIPPING AND FALLING FROM A STANDING POSITION AND LANDED DIRECTLY INTO THE RIGHT ELBOW. THE PATIENT HAD THE ONSET OF PAIN AND INABILITY TO FULLY USE THE ELBOW. SUBSEQUENT X-RAYS WERE TAKEN AND REVEALED A DISPLACED, DISTRACTED OLECRANON FRACTURE, WITH A COMMINUTED RIGHT RADIAL HEAD FRACTURE. THE PATIENT ALSO COMPLAINS OF PAIN IN THE RIGHT PROXIMAL HUMERUS. THE PATIENT WAS ORIGINALLY IMPLANTED ON (B)(6) 2014 WITH ONE (1) VARIABLE ANGLE ¿ LOCKING COMPRESSION PLATE (VA-LCP) PROXIMAL, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 16MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 20MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 24MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 30MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 40MM, ONE (1) LOCKING SCREW SELF-TAPPING WITH STARD

  Patient problems: Bone Fracture(s); Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8692616 ↗
• InjuryJun 10, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO PAIN. ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE POSTEROLATERAL DISTAL HUMERUS PLATES WITH LATERAL SUPPORT, ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE EXTENDED MEDIAL DISTAL HUMERUS PLATES, ONE (1) CORTEX SCREW SELF-TAPPING 50MM, ONE (1) CORTEX SCREW SELF-TAPPING 20MM, ONE (1) CORTEX SCREW SELF-TAPPING 24MM, THREE (3) CORTEX SCREWS SELF-TAPPING 20MM, ONE (1) CORTEX SCREW SELF-TAPPING 22MM, ONE (1) CORTEX SCREW SELF-TAPPING 26MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14MM, ONE VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 16MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 22MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 30MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 40MM AND ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 50MM. SOME SCREWS WERE BROKEN AND LEFT. OTHER SCREWS WERE LEFT IN THE BODY. IT IS UNKNOWN IF WHAT SCREWS WERE LEFT/BROKEN. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. P

  Patient problems: Pain

  MAUDE report 8684353 ↗
• InjuryMay 24, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THERE WERE SEVEN (7) PLATES AND TWENTY-SIX (26) SCREWS REMOVED. THIS COMPLAINT INVOLVES THIRTY-THREE (33) DEVICES. THIS IS REPORT 1 OF 9 FOR (B)(4). THIS COMPLAINT HAS BEEN UPDATED WITH THE 21 OF 33 DEVICES. PLEASE SEE THE LINKED COMPLAINTS (B)(4) FOR ADDITIONAL DEVICES.

  Patient problems: No Code Available

  MAUDE report 8641427 ↗
• InjuryMay 24, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THERE WERE SEVEN (7) PLATES AND TWENTY-SIX (26) SCREWS REMOVED. THIS COMPLAINT INVOLVES THIRTY-THREE (33) DEVICES. THIS IS REPORT 4 OF 10 FOR (B)(4). THIS COMPLAINT HAS BEEN UPDATED WITH THE 4 OF 33 DEVICES. PLEASE SEE THE LINKED COMPLAINTS (B)(4), (B)(4), AND (B)(4) FOR ADDITIONAL DEVICES.

  Patient problems: Bone Fracture(s); Nonunion/Delayed-union Bone Fracture

  MAUDE report 8640316 ↗
• InjuryMar 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED INITIALLY WITH A LEFT ELBOW CONSTRUCT CONSISTING OF TWO (2) UNKNOWN PLATES AND UNKNOWN QUANTITY OF SCREWS ON (B)(6) 2017 FOR AN UNKNOWN FRACTURE. SUBSEQUENTLY, THE PATIENT NOTICED THAT ONE (1) OF THE SCREWS WAS PROMINENT AND THAT IT COULD BE FELT ON THE SKIN. THE PATIENT ALSO WAS IN PAIN DUE TO THE SAME. THIS WAS ALSO REPORTED TO BE EVIDENT IN THE POST-OPERATIVE FOLLOW-UP X-RAYS (UNAVAILABLE) TAKEN ON AN UNKNOWN DATE. HENCE, THE SURGEON DECIDED TO REVISE THE SCREW WITH ANOTHER SIMILAR SCREW. PATIENT UNDERWENT REVISION OF ONE (1) 2.7 MM VARIABLE ANGLE (VA) LOCKING SCREW IN THE LEFT ELBOW ON (B)(6) 2018. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY, UNEVENTFULLY AND WITHOUT ANY SURGICAL DELAY. THE PATIENT WAS REPORTED TO BE IN GOOD HEALTH AT THE END OF THE SURGERY. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR A SCREW. CONCOMITANT DEVICES REPORTED: UNKNOWN PLATES (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 2); UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN).

  Patient problems: No Code Available; Pain; Skin Irritation

  MAUDE report 7342363 ↗
• MalfunctionDec 1, 2017Fitting Problem; Fitting Problem

  IT WAS REPORTED DURING AN INITIAL SURGERY ON (B)(6) 2017, A 2.7MM VARIABLE ANGLE LOCKING SCREW WOULD NOT LOCK INTO THE LOCKING HOLE OF A 2.7MM/3.5MM VARIABLE LOCKING COMPRESSION (LCP) OLECRANON PLATE. THE SURGEON INITIALLY USED A LOCKING TOWER AS OPPOSED TO A VARIABLE ANGLE CONE TO TIGHTEN THE SCREW WHICH MAY HAVE LED TO THE SCREW NOT PROPERLY LOCKING. AFTER FAILED ATTEMPTS OF SECURING THE SCREW IT WAS REMOVED AND DISCARDED. A NEW SIMILAR SCREW WAS USED TO REPLACE THE INITIAL SCREW PLACING IT THROUGH A DIFFERENT HOLE ON THE PLATE. THERE WAS APPROXIMATELY ONE (1) MINUTE DELAY TO REPLACE THE SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT OUTCOME WAS NOTED AS STABLE. CONCOMITANT PART: 2.7MM/3.5MM VARIABLE LCP OLECRANON PLATE 4H/RT116MM (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.7MM VA LOCKING SCREW THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7075885 ↗