NA 201.762Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982142733), received between May 3, 2019 and Jan 31, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT (B)(6) 2022, DURING A PROCEDURE THE SURGEON BROKE THE HEAD OF A 2.4 CORTEX SCREW WHILE PUTTING THE SCREW INTO THE TIBIA. THE HEAD WAS REMOVED AND THE SHAFT WAS RETAINED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNK - SCREWDRIVERS: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1) THIS REPORT IS FOR ONE (1) 2.4 CORTEX SCREW SLF-TPNG T8 SD REC 12. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4)..

  Patient problems: Foreign Body In Patient

  MAUDE report 13403478 ↗
• MalfunctionMay 3, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, POST-OPERATIVE, THE SCRUB NOTED FOLLOWING ON THE BACK TABLE: ONE (1) CORTEX SCREW 18MM BECAME INCARCERATED IN THE GUIDE BLOCK. ADDITIONALLY, THREE (3) CORTEX SCREWS 12MM, THREE (3) CORTEX SCREWS 14MM, ONE (1) CORTEX SCREW 16MM THREE (3) CORTEX SCREWS 18MM, ONE (1) CORTEX SCREW 22MM, TWO (2) CORTEX SCREW 24MM, AND ONE (1) CORTEX SCREW 28MM WOULD NOT FIT THROUGH THE GUIDE BLOCK. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES 16 DEVICES DUE TO THE SYSTEM LIMITATION, THIS INCIDENT WILL BE CAPTURED UNDER THIS (B)(4) (10 DEVICES) AND LINKED (B)(4) (6 DEVICES). THIS REPORT IS FOR ONE (1) 2.4MM CORTEX SCREW 12MM. THIS IS REPORT 3 OF 10 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8579520 ↗
• MalfunctionMay 3, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, POST-OPERATIVE, THE SCRUB NOTED FOLLOWING ON THE BACK TABLE: ONE (1) CORTEX SCREW 18MM BECAME INCARCERATED IN THE GUIDE BLOCK. ADDITIONALLY, THREE (3) CORTEX SCREWS 12MM, THREE (3) CORTEX SCREWS 14MM, ONE (1) CORTEX SCREW 16MM THREE (3) CORTEX SCREWS 18MM, ONE (1) CORTEX SCREW 22MM, TWO (2) CORTEX SCREW 24MM, AND ONE (1) CORTEX SCREW 28MM WOULD NOT FIT THROUGH THE GUIDE BLOCK. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES 16 DEVICES DUE TO THE SYSTEM LIMITATION, THIS INCIDENT WILL BE CAPTURED UNDER THIS (B)(4) (10 DEVICES) AND LINKED (B)(4) (6 DEVICES). THIS REPORT IS FOR ONE (1) 2.4MM CORTEX SCREW 12MM. THIS IS REPORT 2 OF 10 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8579511 ↗

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-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-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-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-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-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