NA 02.211.022Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982053626), received between Jul 9, 2018 and May 3, 2023 — classified as 11 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (1 report).

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.

• MalfunctionMay 3, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEM NUMBER WAS 02.211.022 X 1 WAS MISSING THE PACKAGE WAS EMPTY. IT WAS COMPLETELY SEALED BUT ITEM WAS MISSING PRODUCT FROM PLASTIC PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 22. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16864675 ↗
• InjuryApr 12, 2022Adverse 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 HAD A DISPLACED COMMINUTED ACUTE OLECRANON FRACTURE RIGHT ELBOW WHICH WAS FIXED WITH A SYNTHES OLECRANON LOCKING PLATE, 5 SCREWS IN THE SHAFT WITH BICORTICAL FIXATION, AND 4 LOCKING UNICORTAL SCREWS IN THE PROXIMAL SEGMENT. ON OR ABOUT (B)(6) 2016, SYNTHES ANNOUNCED A RECALL OF THE SYSTEM DUE TO THE DISCOVERY THAT THE SYSTEM WAS DEFECTIVE AND COULD CAUSE THE RADIAL STEM TO LOOSEN POST-OPERATIVELY AT THE STEM BONE INTERFACE. ON (B)(6) 2017, THE PATIENT UNDERWENT REVISION DUE TO PAIN, RIGHT ELBOW RETAINED HARDWARE, OSTEOLYSIS SECONDARY TO LOOSE IMPLANT - RADIAL HEAD, AND FAILED RADIAL HEAD ARTHROPLASTY. OPERATIVE FINDINGS DISCOVERED HYPERTHROPY AND SYNOVITIS, CHONDROMALACIS OF CAPITELLUM GRADE II, GRADE II WITH PERIPHERAL SPUR. THE OLECRANON FRACTURE HEALED WITHOUT ANY LOOSENING OR EVIDENCE OF ANY OSTEOLYSIS AROUND OLECRANON PLATE AND SCREWS. THIS IS REPORT 10 OF 12 FOR (B)(4).

  Patient problems: Muscle/Tendon Damage; Pain

  MAUDE report 14085668 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, ON OR ABOUT (B)(6) 2019 THE PATIENT HAD OPEN REDUCTION ULNAR FRACTURE PROXIMAL END WITH INTERNAL FIXATION OF HIS RIGHT ELBOW. ON OR ABOUT (B)(6) 2020 PATIENT WAS ADMITTED AND HAD AN INCISION, DRAINAGE, AND TREATMENT FOR INFECTION FROM HIS SURGICAL SITE. ON OR ABOUT (B)(6) 2021, THE PATIENT'S INFECTED HARDWARE WAS REMOVED FROM HIS BODY. THIS REPORT IS FOR ONE (1) 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 22. THIS IS REPORT 7 OF 10 FOR COMPLAINT. PRODUCT COMPLAINT (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 12860566 ↗
• InjuryJan 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) CAPTURES THE REVISION PROCEDURE THE PATIENT UNDERWENT DUE TO NONUNION, LEFT DISTAL HUMERAL SHAFT AND BROKEN SCREWS.

  Patient problems: Bone Fracture(s); Post Operative Wound Infection

  MAUDE report 11216523 ↗
• MalfunctionDec 15, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO A BROKEN VARIABLE ANGLE-LOCKING COMPRESSION (VA-LCP) DISTAL HUMERAL PLATE. INITIALLY, THE PATIENT WAS IMPLANTED WITH THE REPORTED DEVICE THREE (3) WEEKS AGO. DURING THE REVISION PROCEDURE, THE BROKEN PLATE WAS REMOVED, AND THE PATIENT WAS REVISED TO ANOTHER PLATE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS, AND SURGICAL OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY 5), VA LOCKING SCREW (PART 02.211.050, LOT UNKNOWN, QUANTITY 1), VA LOCKING SCREW (PART 02.211.018, LOT UNKNOWN, QUANTITY 1), VA LOCKING SCREW (PART 02.211.020, LOT UNKNOWN, QUANTITY 1), VA LOCKING SCREW (PART 02.211.028, LOT UNKNOWN, QUANTITY 1). DURING THE INVESTIGATION BY THE MANUFACTURER, IT WAS NOTED THE LOCKING SCREW WAS STRIPPED. THIS REPORT IS FOR A LOCKING SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11011762 ↗
• 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) 2017, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION WITH PLATES AND SCREWS AND COMPRESSION DUE TO NONUNION LEFT PROXIMAL ULNA S/P ORIF MONTEGGIA FRACTURE SUBLUXATION. ON (B)(6) 2017, THE PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION OF THE COMMINUTED LEFT PROXIMAL ULNA AND WHERE A SYNTHES DEVICE WAS IMPLANTED. PRIOR TO THE REPORTED EVENT, THE PATIENT TRIPPED OVER A CURB AND FELL HER ON HER LEFT UPPER EXTREMITY RESULTING TO AN IMMEDIATE SEVERE PAIN. CONCOMITANT DEVICES REPORTED: 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 24MM (PART NUMBER 201.374.97, LOT UNKNOWN, QUANTITY 1), 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 18MM (PART NUMBER 212.105, LOT UNKNOWN, QUANTITY 1), 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 METAPHYSEAL SCR SLF-TPNG W/T8 STRDRV RECESS/34MM (PART NUMBER 02.118.534, LOT UNKNOWN, QUANTITY 1), 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM (PART NUMBER 02.211.020, LOT UNKNOWN, QUANTITY 2), 2.7MM VA LCKNG SCREW SLF-TPNG WITH T

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

  MAUDE report 10444694 ↗
• 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 8684349 ↗
• InjuryDec 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2018, DUE TO A NONUNION AND HARDWARE FAILURE. PATIENT INITIALLY HAD AN OPEN REDUCTION AND INTERNAL FIXATION SURGERY ON (B)(6) 2018, TO TREAT A LEFT DISTAL HUMERUS FRACTURE. THE IMPLANTED DEVICES WERE VARIABLE ANGLE DISTAL HUMERUS PLATE, VARIABLE ANGLE-LCP LAT DISTAL HUMERUS PLATE, EIGHT (8) VARIABLE ANGLE LOCKING SCREW SELF-TPING WITH T8 STARDRIVE, VARIABLE ANGLE LOCKING SCREW SELF-TPING WITH T8 STARDRIVE, VARIABLE ANGLE-LCP PROXIMAL OLECRANON, AND FOUR (4) ORTEX SCREW SELF- TAPPING. THE PROCEDURE WAS COMPLETED, AND ALL HARDWARE WAS REMOVED INTACT. THE FRACTURE WAS REDUCED, AND AN UNKNOWN VARIABLE ANGLE ELBOW PLATE WITH UNKNOWN SCREWS WERE USED FOR FIXATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS STABLE. THIS REPORT IS FOR ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 22MM THIS IS REPORT 2 OF 10 FOR (B)(4). DUE TO A LIMIT OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT IS A CONTINUATION FROM COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); Impaired Healing

  MAUDE report 8128845 ↗
• InjuryNov 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MODIFIED EVENT DESCRIPTION UPDATE: (B)(6) 2018: IT WAS REPORTED PATIENT WAS IMPLANTED WITH A VARIABLE ANGLE LOCKING COMPRESSION (VA LCP) POSTEROLATERAL DISTAL HUMERUS PLATE, THREE (3) CORTEX SCREWS, AND THREE (3) VA LOCKING SCREWS ON (B)(6) 2018 FOR A RIGHT DISTAL HUMERUS FRACTURE. DURING A POST-OPERATIVE VISIT, SURGEON DETERMINED THAT THE WHOLE CONSTRUCT FELL APART AND THERE WAS INADEQUATE FIXATION FOR THE FRACTURE TYPE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE SURGEON REMOVED THE IMPLANTS. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. REVISION SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 8071512 ↗
• InjuryNov 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS IMPLANTED WITH A VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA LCP) POSTEROLATERAL DISTAL HUMERUS PLATE, ONE (1) 20MM CORTEX SCREW, TWO (2) 18MM CORTEX SCREW, ONE (1) 16MM VA LOCKING SCREW, AND TWO (2) 22MM VA LOCKING SCREWS ON (B)(6) 2018 FOR A RIGHT DISTAL HUMERUS FRACTURE. DURING A POST-OPERATIVE VISIT, SURGEON DETERMINED THERE WAS INADEQUATE FIXATION FOR THE FRACTURE TYPE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE SURGEON REMOVED THE IMPLANTS. IT IS NOT KNOWN WHAT ADDITIONAL HARDWARE WAS IMPLANTED. REVISION SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 2.7MM/3.5MM VA LOCKING SCREW 22MM. THIS IS REPORT 2 OF 7 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8071486 ↗
• InjuryOct 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, A FIELD STOCKING LOCATION (FSL) KIT THAT WAS DELIVERED TO THE FACILITY WAS MISSING A LOCKING VARIABLE ANGLE (VA) SCREW WHICH WAS REQUIRED FOR THE IMPLANTATION OF A CLAVICLE PLATE. THIS PARTICULAR TRAY HAD A BILL OF MATERIALS (BOM). THE FSL DEPARTMENT WAS NOT ABLE TO UPDATE ERRORS OF THE BOM OF KITS. THE SURGEON USED A REGULAR LOCKING SCREW TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT STATUS WAS STABLE. THIS REPORT IS FOR A 2.7MM VA LOCKING SCREW 22MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8004461 ↗
• InjuryOct 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A HARDWARE REMOVAL ON (B)(6) 2018 DUE TO A DRAINING WOUND. IT IS UNKNOWN WHEN THE DEVICES WERE IMPLANTED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT AND SURGICAL OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS IS REPORT 3 OF 8 FOR (B)(4).

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7924039 ↗
• MalfunctionSep 28, 2018Fitting Problem; Device Damaged by Another Device; Device-Device Incompatibility; Fitting Problem; Device Damaged by Another Device; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE VARIABLE ANGLE (VA) SELF TAPPING LOCKING SCREW WENT THROUGH THE VA LOCKING COMPRESSION PLATE (LCP) POSTEROLATERAL DISTAL HUMERUS PLATE. THE SURGEON WAS USING THE VA ELBOW SYSTEM. THE CASE WAS GOING FINE UNTIL THE LAST SCREW PLACEMENT INTO THE PLATE. THE SURGEON PRE-DRILLED WITH A DRILL BIT ON A NOMINAL ANGLE. THE SURGEON POWERED THE LOCKING SCREW DOWN, AND STOPPED SHORT OF THE PLATE AND WENT TO TIGHTEN BY HAND AND THE SCREW WENT DIRECTLY THROUGH PLATE COUNTERSINKING INTO THE BONE. THE SCREW WAS NOT INTO THE JOINT SO THE SURGEON DECIDED TO LEAVE THE SCREW IMPLANTED IN THE BONE. NO ACTION WAS DONE DUE TO IT WOULD REQUIRE TAKING ALL OF THE SCREWS AND THE PLATE OFF AND STARTING OVER. IF THE SCREW MIGRATES INTO THE JOINT, THE PATIENT WOULD HAVE TO COME BACK FOR A REVISION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT AND SURGICAL OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: DRILL / DRILL BIT (PART# 323.062 LOT# UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE, - VARIABLE ANGLE (VA) SELF TAPPING LOCKING SCREW. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7920760 ↗
• InjuryJul 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OSTEOTOMY OF THE OLECRANON ON (B)(6) 2018 TO FIX THE HUMERUS. THE OSTEOTOMY WAS REPAIRED WITH AN OLECRANON PLATE, 2 CORTEX SCREWS, AND 4 VARIABLE ANGLE (VA) LOCKING SCREWS. ON (B)(6) 2018 THE PATIENT HAD A REMOVAL OF VARIABLE ANGLE LOCKING COMPRESSION PLATE DUE TO NON-UNION. IT WAS NOTED THAT THE PROXIMAL OLECRANON DID NOT HEAL AND THE PIECE OF BONE CAME OUT OF THE SCREW PLATE CONSTRUCT, AND PATIENT ALSO EXPERIENCED MALUNION AND DECREASED RANGE OF MOTION. THERE WAS NO OTHER MEDICAL INTERVENTION REQUIRED. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENTS' PROXIMAL OLECRANON WAS REMOVED AND THE PATIENT OUTCOME WAS STABLE. THIS IS REPORT 4 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Impaired Healing; Loss of Range of Motion; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7671445 ↗