NA 02.211.048Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982053756), received between Dec 4, 2018 and Feb 25, 2021 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT UNDERWENT AN UNKNOWN PROCEDURE. INTRA-OPERATIVELY, SOME OF THE LOCKING SCREWS WOULD NOT LOCK INTO THE PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/12 HOLES/RIGHT (PART # 02.118.210, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1)2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 48MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11381782 ↗
• 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 3 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10553618 ↗
• InjuryDec 20, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT SCHEDULED REMOVAL HARDWARE OF A VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) OLECRANON PLATE, UPON REMOVING THE PROXIMAL 2.7 MM VA SCREWS, 2 OF THE 3 SCREWS BROKE JUST BELOW THE HEAD OF THE SCREW. MULTIPLE ATTEMPTS WERE MADE USING THE BROKEN SCREW REMOVAL INSTRUMENTS TO REMOVE THE SCREWS FROM THE SYNTHES BROKEN SCREW REMOVAL SET, WHICH WERE UNSUCCESSFUL. HARDWARE WAS LEFT IN THE EXTREMITY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH TEN (10) MINUTES OF SURGICAL DELAY. PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN BROKEN SCREW REMOVAL INSTRUMENTS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9507688 ↗
• InjuryDec 20, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT SCHEDULED REMOVAL HARDWARE OF A VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) OLECRANON PLATE, UPON REMOVING THE PROXIMAL 2.7MM VA SCREWS, 2 OF THE 3 SCREWS BROKE JUST BELOW THE HEAD OF THE SCREW. MULTIPLE ATTEMPTS WERE MADE USING THE BROKEN SCREW REMOVAL INSTRUMENTS TO REMOVE THE SCREWS FROM THE SYNTHES BROKEN SCREW REMOVAL SET, WHICH WERE UNSUCCESSFUL. HARDWARE WAS LEFT IN THE EXTREMITY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH TEN (10) MINUTES OF SURGICAL DELAY. PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN BROKEN SCREW REMOVAL INSTRUMENTS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9507684 ↗
• MalfunctionDec 19, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2018, A SURGICAL TECHNICIAN PULLED OUT THE VARIABLE ANGLE LOCKING SCREW TO BE IMPLANTED AND HANDED IT TO THE SURGEON DURING AN UNKNOWN PROCEDURE. THE SURGEON NOTICED THAT THE VA LOCKING SCREW WAS BENT BEFORE IMPLANTING IT INTO THE PATIENT. THE SCREW WAS REPLACED WITH AN UNBENT SCREW AND THE PROCEDURE CONTINUED. PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 48MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8180296 ↗
• 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 48MM THIS IS REPORT 7 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 8129367 ↗