NA 212.814Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982152848), received between Oct 19, 2018 and Sep 15, 2026 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 reports).

11 other recalls cover devices cleared under the same FDA submission (K012114, K040588, K050110, K063049, K102694, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50771730 ↗
• MalfunctionSep 15, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50771723 ↗
• MalfunctionSep 15, 2026Device-Device Incompatibility

  It was reported that there was frequent issues getting 2.4mm locking screws to engage near cortex. Customer did not specify any particular screw length, but thinks it happens with all lengths that customer uses.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50771720 ↗
• MalfunctionSep 15, 2026Device-Device Incompatibility

  It was reported that there was frequent issues getting 2.4mm locking screws to engage near cortex. Customer did not specify any particular screw length but thinks it happens with all lengths that customer uses.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50771711 ↗
• InjuryJun 23, 2025Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT FELL OFF HER BIKE. SHE SUSTAINED A LEFT POSTEROLATERAL ELBOW DISLOCATION AND OTHER INJURIES. ON (B)(6) 2024 THE PATIENT UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION OF A CLOSED DISPLACED FRACTURE OF THE RADIAL HEAD/NECK, PRIMARY REPAIR OF LATERAL ULNAR COLLATERAL LIGAMENT USING LOCAL TISSUE, AND OPEN TREATMENT OF THE ELBOW DISLOCATION. A RADIAL HEAD FRACTURE FRAGMENT WAS EXCISED AND THE REMAINING RADIAL HEAD WAS ANATOMICALLY REDUCED AND STABILIZED USING A 2.4MM LOCKING COMPRESSION PLATE. THE LATERAL ULNAR COLLATERAL LIGAMENT WAS REPAIRED USING A METAL ANCHOR AND FIBERWIRE. THE PROCEDURE WAS UNSUCCESSFUL IT SOUNDS LIKE A FAILURE OF THE HARDWARE. A CT SCAN ON (B)(6) 2025 REVEALED THAT SOME VOLAR FRAGMENTS NOT INCLUDED IN THE FIXATION APPEARED INCREASINGLY DISPLACED. THERE WAS ALSO CONCERNED FOR POSSIBLE LOOSENING OR INFECTION AT THE LATERAL EPICONDYLE ANCHOR, ALONG WITH SMALL BONY FRAGMENTS IN THE POSTEROLATERAL ELBOW. THIS COMPLAINT INVOLVES SIX (6) DEVICES.

  Patient problems: Fatigue; Insufficient Information; Pain

  MAUDE report 22309096 ↗
• InjuryOct 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANTATION PROCEDURE ON (B)(6) 2015, THE PATIENT UNDERWENT AN OPEN TREATMENT OF LEFT ELBOW DISLOCATION WITH PRIMARY REPAIR OF ANTERIOR CAPSULAR AVULSION INJURY, A LEFT ELBOW RADIAL HEAD REPLACEMENT FOR FRACTURE AND A LEFT ELBOW PRIMARY REPAIR OF LATERAL ULNAR COLLATERAL LIGAMENT. ONCE THE INJURY WAS VISIBLE AFTER SUITABLE INCISION WAS MADE, THE SURGEON FOUND AN OBVIOUS CLEAR SOMATIC AVULSION OF THE LATERAL ULNAR COLLATERAL LIGAMENT OFF THE HUMORAL ATTACHMENT POINT, BUT THIS APPEARED TO BE INTACT DISTALLY ON THE ULNA. RADIAL HEAD FRACTURE SHOWED ALMOST FRAGMENTS. AFTER CLEANING THE WOUND SITE FOR BETTER VISUALIZATION OF THE OPERATING SITE, THE ARTICULAR SURFACE WAS LAGGED BACK TOGETHER WITH TWO (2) 2.0 MM LAG SCREWS, WITH HEADS COUNTERSUNK. THIS NOW STABILIZED THE ARTICULAR BLOCKS, WAS DIS-IMPACTED AND THEN A RADIAL HEAD LOCKING PLATE WAS APPLIED. ADDITIONAL LATERAL RADIOGRAPHS AFTER THE PROVISIONAL STABILIZATION SHOWED A NEAR-PERFECT REDUCTION; HOWEVER, THE ELBOW WAS WITH THE ELBOW BEING FULLY SUPINATED OR AT LEAST IN NEUTRAL POSITION. WITHOUT REALIZING THIS, THE SURGEON PROCEEDED TO STABILIZE IT FULLY WITH COMBINATION OF THREE (3) NONLOCKING SCREW

  Patient problems: No Code Available

  MAUDE report 7986504 ↗
• InjuryOct 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANTATION PROCEDURE ON (B)(6) 2015, THE PATIENT UNDERWENT AN OPEN TREATMENT OF LEFT ELBOW DISLOCATION WITH PRIMARY REPAIR OF ANTERIOR CAPSULAR AVULSION INJURY, A LEFT ELBOW RADIAL HEAD REPLACEMENT FOR FRACTURE AND A LEFT ELBOW PRIMARY REPAIR OF LATERAL ULNAR COLLATERAL LIGAMENT. ONCE THE INJURY WAS VISIBLE AFTER SUITABLE INCISION WAS MADE, THE SURGEON FOUND AN OBVIOUS CLEAR SOMATIC AVULSION OF THE LATERAL ULNAR COLLATERAL LIGAMENT OFF THE HUMORAL ATTACHMENT POINT, BUT THIS APPEARED TO BE INTACT DISTALLY ON THE ULNA. RADIAL HEAD FRACTURE SHOWED ALMOST FRAGMENTS. AFTER CLEANING THE WOUND SITE FOR BETTER VISUALIZATION OF THE OPERATING SITE, THE ARTICULAR SURFACE WAS LAGGED BACK TOGETHER WITH TWO (2) 2.0 MM LAG SCREWS, WITH HEADS COUNTERSUNK. THIS NOW STABILIZED THE ARTICULAR BLOCKS, WAS DIS-IMPACTED AND THEN A RADIAL HEAD LOCKING PLATE WAS APPLIED. ADDITIONAL LATERAL RADIOGRAPHS AFTER THE PROVISIONAL STABILIZATION SHOWED A NEAR-PERFECT REDUCTION; HOWEVER, THE ELBOW WAS WITH THE ELBOW BEING FULLY SUPINATED OR AT LEAST IN NEUTRAL POSITION. WITHOUT REALIZING THIS, THE SURGEON PROCEEDED TO STABILIZE IT FULLY WITH COMBINATION OF THREE (3) NONLOCKING SCREW

  Patient problems: No Code Available

  MAUDE report 7986489 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012114, K040588, K050110, K063049, K102694, K103243. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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-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-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
• Z-0167-2016 · Oct 6, 2015 · Terminated
  2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantati
• Z-0380-2014 · Jul 31, 2013 · Terminated
  2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragmen
• Z-0956-2013 · Jan 11, 2013 · Terminated
  Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Cor
• Z-0489-2007 · Dec 5, 2006 · Terminated
  LCP Volar Distal Radius Plate Extra Articular 4H HD-RT-Long, LCP Volar Distal Radius Plate 2.4 mm, Catalog number 242.465