NA 04.210.116Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982118523), received between Oct 3, 2019 and Jul 29, 2022 — classified as 2 injuries.

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

9 other recalls cover devices cleared under the same FDA submission (K071184, K100776, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN FRANCE AS FOLLOWS: THE PATIENT WAS HOSPITALIZED (B)(6) 2022. FOR A FRACTURE OF THE DISTAL RADIUS REDUCED BY OSTEOSYNTHESIS. THE EXACT IMPLANT DATE IS UNKNOWN. THE PATIENT WAS RE-EXAMINED AFTER ONE MONTH AND PRESENTED WITH UNSCREWING OF THE IMPLANTS PLACED AS WELL AS BREAKAGE OF THE 4 DISTAL EPIPHYSEAL LOCKING SCREWS AT THE BODY-HEAD JUNCTION IN THE ABSENCE OF A FALL. ADDITIONALLY SECONDARY DISPLACEMENT OF THE FRACTURE SITE WITH EXTRA-ARTICULAR CALLUS OCCURRED. THE MATERIAL INITIALLY IMPLANTED WAS REMOVED DURING A SURGERY REVISION ON (B)(6) 2022 TO RECTIFY THE CALLUS AND NEW OSTEOSYNTHESIS BY PLATE. THIS IS REPORT 1 OF 9 FOR (B)(4). THIS REPORT IS FOR A LOCKING SCREW.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15131758 ↗
• InjuryOct 3, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR DISTAL RADIUS FRACTURE WITH THE VARIABLE ANGEL-LOCKING COMPRESSION (VA-LCP) TWO-COLUMN VOLAR DISTAL RADIUS PLATE AND THE LOCKING SCREWS. ON (B)(6) 2019, THE PATIENT UNDERWENT THE REMOVAL SURGERY DUE TO BONE HEALING. DURING THE REMOVAL SURGERY, THE SURGEON FOUND THAT THE 2 PROXIMAL SCREWS AND 1 DISTAL SCREW HAD BEEN BROKEN. THE SURGEON COULD REMOVE THE DISTAL SCREW, BUT HE COULDN¿T REMOVE THE 2 PROXIMAL SCREWS BECAUSE THE SURGEON DIDN¿T WANT TO MAKE MORE INCISION. THE 2 SCREWS REMAINED IN THE PATIENT, AND THE SURGEON CLOSED THE INCISION. THE SURGERY WAS DELAYED BY LESS THAN THIRTY (30) MINUTES. AFTER THE SURGERY, THE SURGEON CONFIRMED THAT THE 2 PROXIMAL SCREWS HAD BEEN BROKEN IN (B)(6) 2019, ACCORDING TO THE X-RAYS. THE SURGEON COMMENTED THAT THE SCREWS MIGHT HAVE SOME PROBLEMS. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: TITANIUM VARIABLE ANGLE LOCKING COMPRESSION PLATE (PART #: 04.111.631S, LOT #: L760010, QUANTITY #: 1), TITANIUM VARIABLE LOCKING SCREW (PART #: 04.210.114S, LOT #: UN

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9153586 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071184, K100776, K102694, K103243. One submission often covers many models, so check the product and lot details in each record.

• 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-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-2057-2013 · May 31, 2013 · Terminated
  Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and
• 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