NA 201.766Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982142764), received between Jan 29, 2018 and Jun 23, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (2 reports).

10 other recalls cover devices cleared under the same FDA submission (K002271, K063049, K102694, K103243, K112583); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 22309190 ↗
• MalfunctionJun 30, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, RECEIVED REPLENISHMENT ORDERS FOR FIELD SET AND TWO PACKAGES CONTAINED THE WRONG SCREWS. NO PATIENT INVOLVEMENT, THIS REPORT IS FOR ONE (1) 2.4 CORTEX SCREW SLF-TPNG T8 SD REC 16. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12091916 ↗
• MalfunctionMay 3, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SCRUB TRIED ON THE BACK TABLE AND ONE (1) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 18MM BECAME INCARCERATED IN THE GUIDE BLOCK. ADDITIONALLY, THREE(3) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 12MM, THREE(3) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14MM, THREE(3) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 18MM, ONE (1) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 22MM, TWO (2) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS  24MM, ONE (1) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 28MM WOULD NOT FIT THROUGH THE GUIDE BLOCK. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES SIXTEEN (16) DEVICES. THIS COMPLAINT INVOLVES 16 DEVICES DUE TO THE SYSTEM LIMITATION, THESE INCIDENTS WILL BE CAPTURED UNDER THIS (B)(4) FOR (10 DEVICES) AND LINKED (B)(4) FOR (6 DEVICES). THIS REPORT IS FOR SIX (6) DEVICES. THIS REPORT IS 6 OF 6 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8579779 ↗
• InjuryNov 29, 2018Device Slipped; Device Slipped

  IT WAS NOTED THAT AT THE TIME OF THE REVISION PROCEDURE, THE CLAVICLE FRACTURE WAS NOT HEALED.

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8115677 ↗
• InjuryNov 29, 2018Device Slipped; Device Slipped

  IT WAS NOTED THAT AT THE TIME OF THE REVISION PROCEDURE, THE CLAVICLE FRACTURE WAS NOT HEALED.

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8115631 ↗
• MalfunctionJan 29, 2018Break; Break

  IT WAS REPORTED THAT DURING AN ORIGINAL SURGERY FOR TREATMENT OF A LEFT DISTAL RADIUS FRACTURE ON (B)(6) 2018, THE SCREW HEAD BROKE OFF DURING INSERTION INTO THE SECOND MOST PROXIMAL HOLE OF THE WRIST SPANNING PLATE ON THE RADIUS. THE BROKEN SCREW HEAD WAS REMOVED AND THE REMAINING SCREW SHAFT WAS LEFT IN THE BONE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A REPORTED DELAY OF 1 MINUTE. PATIENT OUTCOME IS STABLE. THIS COMPLAINT IS FOR ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7226388 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K002271, K063049, K102694, K103243, K112583. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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-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