NA 04.112.611SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982279231), received between Aug 31, 2022 and Mar 22, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K201321, K203414); 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.

• InjuryMar 22, 2023No Apparent Adverse Event; No Apparent Adverse Event

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: THIS (B)(4) IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE EVENT WHICH OCCURRED IN THE REMOVAL SURGERY. THIS (B)(4) REPORTS ABOUT THE SCREW BREAKAGE WHICH OCCURRED AFTER THE FIRST SURGERY. IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OSTEOSYNTHESIS SURGERY FOR CLAVICLE SHAFT FRACTURE WITH THE SCREW IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, NAIL EXTRACTION SURGERY WAS PERFORMED AS BONE FUSION WAS ACHIEVED ON (B)(6) 2023. IN THE REMOVAL SURGERY, IT WAS FOUND THAT ONE OF THE NINE SCREWS THAT FIXED THE CLAVICLE PLATE (VA-LCP CLAVICLE PLATE 2.7/04-112-611S) HAD BEEN BROKEN COMPLETELY ON SCREW HEAD SINCE UNKNOWN DATE, WHILE THE OTHER ONE SCREW HAD NOT BEEN COMPLETELY BROKEN BUT BEEN ALMOST BROKEN. THE PLATE WAS REMOVED AND THE SCREWS INCLUDING THE TWO BROKEN SCREW WAS ALSO REMOVED. 2 OF THE 4 SCREW WAS BROKEN, BUT TWO BROKEN SCREWS WERE USED AROUND THE DISTAL CLAVICLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINUTES SURGICAL DELAY. IMPLANT DATE:(B)(6) 2022. EXPLANT DATE:(B)(6) 2023. PATIENT STATUS/ OUTCOME? STABLE. NO FURTHER INFORMATION IS AVA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16589858 ↗
• InjuryAug 31, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY WITH THE IMPLANTS FOR RIGHT DISTAL CLAVICULAR FRACTURE. AFTER SURGERY, WHEN THE PATIENT LIFTED THE AFFECTED SIDE TO REACH FOR SOMETHING AT A HIGH PLACE, A CRACKLING NOISE WAS HEARD. CR IMAGING REVEALED THAT ALL 2.7 MM SCREWS INSERTED IN THE DISTAL PART OF THE FRACTURE WERE BROKEN JUST BELOW THE SCREWHEAD. ALL THE IMPLANTS WILL BE EXTRACTED AND REPLACED WITH A CLAVICLE HOOK PLATE IN A REVISION SURGERY. THE DATE OF THE REVISION SURGERY IS NOT DETERMINED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7MM TI VA LCP CLAVICLE PLATE LATERAL/ CS1/ RIGHT/ STERILE. THIS IS REPORT 1 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 15331813 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201321, K203414. One submission often covers many models, so check the product and lot details in each record.

• Z-1241-2024 · Jan 24, 2024 · Open, Classified
  VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621S