NA 04.211.024Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982119049), received between Aug 4, 2021 and Jun 10, 2026 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE SCREW IN QUESTION. DURING SURGERY, WHEN INSERTING THE SCREW INTO VA-DHP USING THE TORQUE LIMITER, FINAL LOCKING COULD NOT BE COMPLETED. THE SCREWS WERE REPLACED AND THE FINAL LOCKING WAS COMPLETED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINUTES DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25456638 ↗
• MalfunctionOct 22, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT STATUS WAS STABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506434 ↗
• MalfunctionJan 17, 2024Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH VA-DHP IMPLANTS FOR A FRACTURE OF DISTAL COMMISSURE OF LEFT HUMERUS. WHILE THE LOCKING SCREW IN QUESTION WAS BEING INSERTED, THE SCREW HEAD BROKE OFF. THERE WAS NO ADVERSE PATIENT IMPACT. ALL FRAGMENTS WERE REMOVED WITHOUT ADDITIONAL MEDICAL INTERVENTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 24MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18528348 ↗
• MalfunctionNov 30, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 08-NOVEMBER-2023 THE SCREW IN QUESTION WAS FOUND WITH AIR BUBBLES IN THE PACKAGE. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 24MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18237104 ↗
• InjuryOct 3, 2022Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR FRACTURE OF DISTAL CLAVICLE WITH 5 SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6), IT WAS CONFIRMED THAT 5 DISTAL SCREWS WERE BROKEN. IT IS UNKNOWN WHEN THE SCREWS BROKE. THE SURGEON COMMENTED THAT THE CAUSE WAS UNKNOWN. THE PATIENT HAD DEMENTIA. CONCOMITANT DEVICE REPORTED: 2.7 TI VA LCP CLAV PL LAT/ CS1/ LFT/ -S (04.112.610S, 640P853). THIS IS REPORT 8 OF 9 FOR (B)(4). THIS REPORT IS 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 24MM.

  Patient problems: Failure of Implant

  MAUDE report 15530275 ↗
• InjuryOct 3, 2022Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR FRACTURE OF DISTAL CLAVICLE WITH 5 SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6), IT WAS CONFIRMED THAT 5 DISTAL SCREWS WERE BROKEN. IT IS UNKNOWN WHEN THE SCREWS BROKE. THE SURGEON COMMENTED THAT THE CAUSE WAS UNKNOWN. THE PATIENT HAD DEMENTIA. CONCOMITANT DEVICE REPORTED: 2.7 TI VA LCP CLAV PL LAT/ CS1/ LFT/ -S (04.112.610S, 640P853). THIS IS REPORT 1 OF 9 FOR (B)(4). THIS REPORT IS FOR 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 24MM.

  Patient problems: Failure of Implant

  MAUDE report 15529282 ↗
• InjurySep 16, 2022Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. AFTER THE INITIAL SURGERY, TWO SCREWS CAME OUT ON AN UNKNOWN DATE, SO A REVISION SURGERY WAS SCHEDULED FOR AND PERFORMED ON (B)(6) 2022. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 24MM. THIS IS REPORT 3 OF 7 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15438171 ↗
• InjuryAug 4, 2021Migration; Migration

  IT WAS REPORTED THAT PARTS WERE IMPLANTED IN 2017. LAST YEAR THE SCREWS STARTED BACKING OUT, AND THE PLATE AND SCREWS WERE REMOVED IN (B)(6) OF 2020. A NEW PLATE. WAS NOT IMPLANTED AT THAT TIME DUE TO HOSPITAL RESTRICTIONS ON SURGERIES DUE TO COVID. A NEW PLATE WAS IMPLANTED IN (B)(6) 2021. PATIENT STATUS IS UNKNOWN. NO SURGICAL DELAY. THIS COMPLAINT INVOLVES (6) DEVICES. THIS REPORT IS FOR (1) 2.7 TI VAL SCR SLF-TPNG T8 SD REC 24. THIS REPORT IS 3 OF 6 FOR (B)(4).

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

  MAUDE report 12277530 ↗