NA 412.818Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982211637), received between Nov 30, 2017 and Jul 31, 2023 — classified as 3 injuries, 2 malfunctions.

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

11 other recalls cover devices cleared under the same FDA submission (K012114, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM BRAZIL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 IN WHICH THE PRODUCTS IN QUESTION WERE IMPLANTED. THE PATIENT HAS BEEN PRESENTING WITH A REACTION AT THE SITE OF THE PROCEDURE FOR OVER 1 YEAR. PRODUCTS HAVE NOT BEEN EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS FOR A 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 18MM. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17424256 ↗
• MalfunctionAug 17, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING DISTAL RADIUS SURGICAL PROCEDURE ON (B)(6) 2021, IT WAS NOTICED THAT THE 2.4MM LOCKING SCREWS WERE DIFFICULT TO GET ATTACHED ON THE SCREWDRIVER. THERE WAS ONE (1) HOUR SURGICAL DELAY. THE PATIENT OUTCOME IS REPORTED AS SAFE. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 18MM. THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12332394 ↗
• MalfunctionAug 17, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING DISTAL RADIUS SURGICAL PROCEDURE ON (B)(6) 2021, IT WAS NOTICED THAT THE 2.4MM LOCKING SCREWS WERE DIFFICULT TO GET ATTACHED ON THE SCREWDRIVER. THERE WAS ONE (1) HOUR SURGICAL DELAY. THE PATIENT OUTCOME IS REPORTED AS SAFE. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 18MM THIS IS REPORT 2 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12332383 ↗
• InjuryNov 30, 2017Break; Break

  DEVICE REPORT REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2017 DUE TO BROKEN HARDWARE AND NON-UNION OF THE LEFT HAND. THE PATIENT UNDERWENT REDUCTION OF THE LEFT-HAND STRUCTURE TO RESTORE NORMAL INCLINATIONS OF THE DISTAL THIRD RADIUS IN RELATION TO THE ULNA AND CARPAL BONES. THE DEVICES WERE INITIALLY IMPLANTED (B)(6) 2017. THE PATIENT PRESENTED WITH EVIDENCE OF WRIST DEFORMITY AND LOCAL PAIN; ABSENCE OF RADIOGRAPHIC BONE CONSOLIDATION, WAS CONFIRMED BY TOMOGRAPHY. ILIAC CREST AUTOGENOUS BONE GRAFTING WAS PERFORMED. FIXATION WAS DONE WITH NEW ANATOMICAL PLATE FOR DISTAL RADIUS AND LOCKING SCREWS, ONE DAY AFTER ADMISSION. CONCOMITANT DEVICES: LCP VOLAR DISTAL RADIUS PLATE (PART 442.465, LOT UNKNOWN, QUANTITY 1); 2.4MM TI LOCKING SCREW (PART 412.814, LOT 9329097, QUANTITY 2); 2.4MM TI LOCKING SCREW (PART 412.812, LOT 9843385, QUANTITY 1) THIS IS REPORT 2 OF 3 FOR (B)(4).

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

  MAUDE report 7071837 ↗
• InjuryNov 30, 2017Break; Break

  DEVICE REPORT REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2017 DUE TO BROKEN HARDWARE AND NON-UNION OF THE LEFT HAND. THE PATIENT UNDERWENT REDUCTION OF THE LEFT-HAND STRUCTURE TO RESTORE NORMAL INCLINATIONS OF THE DISTAL THIRD RADIUS IN RELATION TO THE ULNA AND CARPAL BONES. THE DEVICES WERE INITIALLY IMPLANTED (B)(6) 2017. THE PATIENT PRESENTED WITH EVIDENCE OF WRIST DEFORMITY AND LOCAL PAIN; ABSENCE OF RADIOGRAPHIC BONE CONSOLIDATION, WAS CONFIRMED BY TOMOGRAPHY. ILIAC CREST AUTOGENOUS BONE GRAFTING WAS PERFORMED. FIXATION WAS DONE WITH NEW ANATOMICAL PLATE FOR DISTAL RADIUS AND LOCKING SCREWS, ONE DAY AFTER ADMISSION. CONCOMITANT DEVICES: LCP VOLAR DISTAL RADIUS PLATE (PART 442.465, LOT UNKNOWN, QUANTITY 1); 2.4MM TI LOCKING SCREW (PART 412.814, LOT 9329097, QUANTITY 2); 2.4MM TI LOCKING SCREW (PART 412.812, LOT 9843385, QUANTITY 1) THIS IS REPORT 1 OF 3 FOR (B)(4).

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

  MAUDE report 7071682 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012114, 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-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-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
• 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