NA 04.211.022Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10886982119032), received between Aug 24, 2022 and May 12, 2025 — classified as 8 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ORIF SURGERY FOR A DISTAL HUMERUS FRACTURE WITH THE VA LOCKING SCREW. THE SURGEON USED THE VA-DHP PLATE 3 HOLES AND INSERTED THE VA LOCKING SCREW TO THE MOST DISTAL MEDIAL HOLE WITH FOLLOWING THE STANDARD VARIABLE ANGLE TECHNIQUE. HOWEVER, THE VA LOCKING SCREW WAS UNABLE TO BE LOCKED WITH THE PLATE AND THE SCREW GOT IDLED. THE SURGEON REMOVED THE VA LOCKING SCREW AND OPENED AND USED ANOTHER NEW SCREW, AND IT WAS LOCKED PROPERLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ABOUT 5 MINUTES OF DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22002526 ↗
• MalfunctionOct 3, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY FOR RIGHT DISTAL HUMERUS FRACTURE WITH VA LOCKING SCREW. THE SURGEON INSERTED THE SCREW IN QUESTION IN VARIABLE ANGLE MODE INTO THE DISTAL VA LOCKING SCREW HOLE TO FIX THE MEDIAL PLATE, HOWEVER THE SCREW HEAD IDLED IN THE HOLE AND FINAL TIGHTENING COULD NOT BE PERFORMED. THE SCREW WAS NOT REINSERTED, SURGERY WAS COMPLETED WITH FIXATION USING THE SCREW IN QUESTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 22MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17859837 ↗
• MalfunctionOct 2, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR CLAVICLE FRACTURE WITH VARIABLE ANGLE (VA) LOCKING SCREW. THE SURGEON INSERTED THE VA LOCKING SCREWS IN THE 4TH, 1ST, AND 3RD ORDER OF THE DISTAL HOLES OF THE PLATE. WHILE INSERTING THE SECOND DISTAL LOCKING SCREW, THE SCREW HEAD BROKE BEFORE TORQUE WAS APPLIED. HOWEVER, THE SURGEON DID NOT FEEL THAT THE SCREW HEAD HAD BROKEN. THIS EVENT WAS CONFIRMED WHEN THE SCRUB NURSE NOTICED THAT THE RETURNED SCREWDRIVER HAD A SCREW HEAD ATTACHED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 22MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 17852988 ↗
• MalfunctionSep 11, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2022, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE PRODUCTS IN QUESTION. ON AN UNKNOWN DATE, THE OLECRANON IMPLANTS WERE REMOVED AS BONE FUSION WAS ACHIEVED. DURING THE PROCEDURE, IT WAS FOUND THAT TWO OF THE SCREWS WERE DIFFICULT TO REMOVE. ONE OF THE SCREWS BROKE IMMEDIATELY UPON TURNING THE SCREW. THE OTHER SCREW BROKE WHEN THE ENTIRE PLATE WAS BEING TURNED WHILE ATTEMPTING TO REMOVE THE SCREW. PATIENT OUTCOME IS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 22MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17718732 ↗
• MalfunctionJul 19, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED DURING A PROCEDURE ON AN UNKNOWN DATE IN 2023, THE SCREW SLIPPED THROUGH PLATE HOLE AND DIDN'T LOCK IN SCREW HOLE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY OR HOW THE PROCEDURE WAS COMPLETED. THIS REPORT IS FOR ONE (1) 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 22MM THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17357021 ↗
• InjuryDec 16, 2022Break; Migration; Break; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT OPEN REDUCTION/INTERNAL FIXATION FOR A FRACTURE OF THE PROXIMAL END OF THE CLAVICLE WITH THE PRODUCTS IN QUESTION. THE SURGERY WAS COMPETED SUCCESSFULLY. LATER, ON AN UNKNOWN DATE, THE SCREWS WERE COMING OUT, SO THESE SCREWS WERE REMOVED ON (B)(6) 2022. TWO SCREWS WERE EXTRACTED. ONE HAD LOOSENING AND THE OTHER WAS BROKEN OFF UNDER THE HEAD. THE SURGEON WAS CONCERNED THAT THE SCREWS HAD COME LOOSE NOT LONG AFTER THE PLATE INSERTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THE PATIENT WAS REPORTED TO BE STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE UNK - SCREWS: TRAUMA. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15997207 ↗
• 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) 2022, 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, (B)(4)). THIS IS REPORT 4 OF 9 FOR (B)(4). THIS REPORT IS 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 22MM.

  Patient problems: Failure of Implant

  MAUDE report 15533736 ↗
• 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 6 OF 9 FOR (B)(4). THIS REPORT IS 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM.

  Patient problems: Failure of Implant

  MAUDE report 15532606 ↗
• 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 7 OF 9 FOR (B)(4). THIS REPORT IS 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM.

  Patient problems: Failure of Implant

  MAUDE report 15532372 ↗
• InjurySep 27, 2022Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT SURGERY FOR A FRACTURE OF ELBOW BONE HEAD WITH THE PLATE AND SCREWS IN QUESTION. ON AN UNKNOWN DATE, THE FIXATION WAS LOST. ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED AND COMPLETED SUCCESSFULLY WITH A NEW PLATE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 22MM. THIS IS REPORT 7 OF 10 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15490711 ↗
• 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 22MM. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15438170 ↗
• 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 22MM. THIS IS REPORT 2 OF 7 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15438167 ↗
• 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 LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 22MM THIS IS REPORT 8 OF 8 FOR COMPLAINT (B)(4).

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

  MAUDE report 15331862 ↗
• MalfunctionAug 24, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DURING AN OSTEOSYNTHESIS FOR RIGHT DISTAL HUMERUS FRACTURE, FOUR (4) CONSECUTIVE LOCKING SCREWS FAILED TO LOCK INTO THE FOUR HOLES OF A PLATE. THE SURGEON HAD BEEN FOLLOWING THE SURGICAL TECHNIQUE AND HAD STARTED INSERTING THE LOCKING SCREWS USING A DRILL SLEEVE. THE SURGEON CONSULTED WITH THE SALES REP AND ULTIMATELY DECIDED TO PROCEED USING A NEW PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH LESS THAN 30 MINUTES OF DELAY. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 22MM. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15285899 ↗
• MalfunctionAug 24, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DURING AN OSTEOSYNTHESIS FOR RIGHT DISTAL HUMERUS FRACTURE, FOUR (4) CONSECUTIVE LOCKING SCREWS FAILED TO LOCK INTO THE FOUR HOLES OF A PLATE. THE SURGEON HAD BEEN FOLLOWING THE SURGICAL TECHNIQUE AND HAD STARTED INSERTING THE LOCKING SCREWS USING A DRILL SLEEVE. THE SURGEON CONSULTED WITH THE SALES REP AND ULTIMATELY DECIDED TO PROCEED USING A NEW PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH LESS THAN 30 MINUTES OF DELAY. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 22MM. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15285896 ↗
• MalfunctionAug 24, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DURING AN OSTEOSYNTHESIS FOR RIGHT DISTAL HUMERUS FRACTURE, FOUR (4) CONSECUTIVE LOCKING SCREWS FAILED TO LOCK INTO THE FOUR HOLES OF A PLATE. THE SURGEON HAD BEEN FOLLOWING THE SURGICAL TECHNIQUE AND HAD STARTED INSERTING THE LOCKING SCREWS USING A DRILL SLEEVE. THE SURGEON CONSULTED WITH THE SALES REP AND ULTIMATELY DECIDED TO PROCEED USING A NEW PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH LESS THAN 30 MINUTES OF DELAY. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 22MM. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15285886 ↗