NA 02.211.012Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982053565), received between Aug 1, 2019 and Nov 13, 2024 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 reports).

7 other recalls cover devices cleared under the same FDA submission (K100776, K103243); they may or may not involve this specific model.

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT WAS INVOLVED AND THE CASE WAS COMPLETED SUCCESSFULLY. THE SCREWS WERE NOT LOCKING.

  Patient problems: Insufficient Information

  MAUDE report 20675960 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, NONUNION OCCURRED AND 6-HOLE VA-LCP MEDIAL DISTAL PLATE WITH SIX 2.7MM VA LOCKING SCREWS, THREE 3.5 CORTICAL SCREWS, AND ONE 3.5 LOCKING SCREW WERE ALL REMOVED. THE SCREW HEAD MAY HAVE ALREADY BEEN BROKE PRIOR TO THE REMOVAL CASE. THERE WAS NO SURGICAL DELAY REPORTED. THE PATIENT WAS STABLE AFTER THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES TWELVE (12) DEVICES. THIS REPORT IS FOR (1) 2.7MM VA LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM. THIS IS REPORT 9 OF 10 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10818366 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, NONUNION OCCURRED AND 6-HOLE VA-LCP MEDIAL DISTAL PLATE WITH SIX 2.7MM VA LOCKING SCREWS, THREE 3.5 CORTICAL SCREWS, AND ONE 3.5 LOCKING SCREW WERE ALL REMOVED. THE SCREW HEAD MAY HAVE ALREADY BEEN BROKE PRIOR TO THE REMOVAL CASE. THERE WAS NO SURGICAL DELAY REPORTED. THE PATIENT WAS STABLE AFTER THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES TWELVE (12) DEVICES. THIS REPORT IS FOR (1) 2.7MM VA LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM. THIS IS REPORT 8 OF 10 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10818364 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, NONUNION OCCURRED AND 6-HOLE VA-LCP MEDIAL DISTAL PLATE WITH SIX 2.7MM VA LOCKING SCREWS, THREE 3.5 CORTICAL SCREWS, AND ONE 3.5 LOCKING SCREW WERE ALL REMOVED. THE SCREW HEAD MAY HAVE ALREADY BEEN BROKE PRIOR TO THE REMOVAL CASE. THERE WAS NO SURGICAL DELAY REPORTED. THE PATIENT WAS STABLE AFTER THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES TWELVE (12) DEVICES. THIS REPORT IS FOR (1) 2.7MM VA LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM. THIS IS REPORT 6 OF 10 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10818357 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, NONUNION OCCURRED AND 6-HOLE VA-LCP MEDIAL DISTAL PLATE WITH SIX 2.7MM VA LOCKING SCREWS, THREE 3.5 CORTICAL SCREWS, AND ONE 3.5 LOCKING SCREW WERE ALL REMOVED. THE SCREW HEAD MAY HAVE ALREADY BEEN BROKE PRIOR TO THE REMOVAL CASE. THERE WAS NO SURGICAL DELAY REPORTED. THE PATIENT WAS STABLE AFTER THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES TWELVE (12) DEVICES. THIS REPORT IS FOR (1) 2.7MM VA LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM. THIS IS REPORT 7 OF 10 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10818356 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, NONUNION OCCURRED AND 6-HOLE VA-LCP MEDIAL DISTAL PLATE WITH SIX 2.7MM VA LOCKING SCREWS, THREE 3.5 CORTICAL SCREWS, AND ONE 3.5 LOCKING SCREW WERE ALL REMOVED. THE SCREW HEAD MAY HAVE ALREADY BEEN BROKE PRIOR TO THE REMOVAL CASE. THERE WAS NO SURGICAL DELAY REPORTED. THE PATIENT WAS STABLE AFTER THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES TWELVE (12) DEVICES. THIS REPORT IS FOR (1) 2.7MM VA LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM. THIS IS REPORT 5 OF 10 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10818355 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, NONUNION OCCURRED AND 6-HOLE VA-LCP MEDIAL DISTAL PLATE WITH SIX 2.7MM VA LOCKING SCREWS, THREE 3.5 CORTICAL SCREWS, AND ONE 3.5 LOCKING SCREW WERE ALL REMOVED. THE SCREW HEAD MAY HAVE ALREADY BEEN BROKE PRIOR TO THE REMOVAL CASE. THERE WAS NO SURGICAL DELAY REPORTED. THE PATIENT WAS STABLE AFTER THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES TWELVE (12) DEVICES. THIS REPORT IS FOR (1) 2.7MM VA LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10818347 ↗
• InjuryOct 28, 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 10752295 ↗
• MalfunctionDec 10, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, THE VARIABLE ANGLE (VA) LOCKING SCREW WAS ORDERED FOR RESTOCKING. THE SALES CONSULTANT OPENED THE BAG AND FELT THAT THERE WAS NO SCREW IN THERE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9445791 ↗
• InjurySep 16, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE THE SURGEON WAS USING A VARIABLE ANGLE LATERAL DISTAL FIBULA PLATE AND PLACED A VARIABLE ANGLE THREADED DRILL GUIDE FROM THE UNIVERSAL SMALL FRAGMENT (USF) INTO THE PLATE AND DRILLED WITH A 2.0 DRILL BIT FOR 2.7 VARIABLE ANGLE LOCKING SCREWS, TWO (2) OF THE HOLES WOULD NOT LOCK AND THE SCREWS WOULD JUST SPIN IN THE LOCKING HOLE DURING OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE ANKLE. TOTAL 5 SCREWS WERE USED AND WOULD NOT LOCK. THERE WAS A SURGICAL DELAY OF THIRTY (30) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING A DIFFERENT 2.7/3.5 VARIABLE ANGLE LATERAL DISTAL FIBULA PLATE AND DIFFERENT SCREWS. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK - GUIDES/SLEEVES/AIMING: GUIDE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNK - DRILL BITS: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1) THIS REPORT IS FOR ONE (1) 2.7MM VA LOCKING SCREW 12MM. THIS IS REPORT 5 OF 6 FOR COMPLAINT.

  Patient problems: No Code Available

  MAUDE report 9072343 ↗
• InjurySep 16, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE THE SURGEON WAS USING A VARIABLE ANGLE LATERAL DISTAL FIBULA PLATE AND PLACED A VARIABLE ANGLE THREADED DRILL GUIDE FROM THE UNIVERSAL SMALL FRAGMENT (USF) INTO THE PLATE AND DRILLED WITH A 2.0 DRILL BIT FOR 2.7 VARIABLE ANGLE LOCKING SCREWS, TWO (2) OF THE HOLES WOULD NOT LOCK AND THE SCREWS WOULD JUST SPIN IN THE LOCKING HOLE DURING OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE ANKLE. TOTAL 5 SCREWS WERE USED AND WOULD NOT LOCK. THERE WAS A SURGICAL DELAY OF THIRTY (30) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING A DIFFERENT 2.7/3.5 VARIABLE ANGLE LATERAL DISTAL FIBULA PLATE AND DIFFERENT SCREWS. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK - GUIDES/SLEEVES/AIMING: GUIDE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNK - DRILL BITS: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) 2.7MM VA LOCKING SCREW 12MM. THIS IS REPORT 2 OF 6 FOR COMPLAINT.

  Patient problems: No Code Available

  MAUDE report 9072235 ↗
• MalfunctionAug 1, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CUSTOMER RECEIVED THE PACKAGE FOR VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS WITH NO PRODUCT. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8850308 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100776, K103243. One submission often covers many models, so check the product and lot details in each record.

• Z-0882-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0881-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0879-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0880-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0883-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-2389-2016 · Jun 28, 2016 · Terminated
  Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone,
• Z-0323-2016 · Nov 2, 2015 · Terminated
  2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone frag