NA 04.118.516Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982108807), received between Jul 25, 2022 and May 25, 2023 — classified as 2 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K120070, K120717, K120854); 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.

• MalfunctionMay 25, 2023Break; Break

  DEVICE REPORT FROM 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 A CLAVICLE FRACTURE WITH LOW PROFILE METAPHYSEAL COMPRESSION SCREW AND VA-LCP CLAVICLE PLATE. THE SURGEON USED A LOW-PROFILE SCREW TO FIX THE REGULAR HOLE BECAUSE OF THE YOUNG PATIENT. THE SURGEON DRILLED WITH A THREADED DRILL GUIDE AS INSTRUCTED IN THE PROCEDURE MANUAL, AND USED A SCREWDRIVER WITHOUT TORQUE LIMITER TO INSERT A SCREW. HOWEVER, IT REACHED TO THE LATERAL CORTEX AND BROKE OFF FROM THE HEAD OF THE SCREW WHEN IT WAS SLIGHTLY RETIGHTENED. THE SCREW COULD NOT BE REMOVED, BUT THE SURGEON DECIDED TO LEAVE IT IN THE BODY BECAUSE IT WAS SCHEDULED FOR REMOVAL AFTER FUSION. THIS REPORT INVOLVES ONE 2.7MM TI METAPHYSEAL SCR/SLF- TPNG W/T8 STRDRV RECESS/16MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17005550 ↗
• MalfunctionJul 25, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OSTEOSYNTHESIS FOR RIGHT CLAVICULAR SHAFT FRACTURE. WHILE GRASPING THE CENTRAL BONE FRAGMENT AND PERIPHERAL BONE FRAGMENT WITH BONE GRASPING FORCEPS, THE SURGEON INSERTED THE SCREW IN QUESTION (2.7 MM LWPROF METAPHYS COMPRES SCREW) INTO THE CENTRAL BONE FRAGMENT AND THEN INSERTED A 2.7 VALHS INTO THE PERIPHERAL BONE FRAGMENT. WHEN ANOTHER 2.7 VALHS WAS INSERTED INTO THE CENTRAL BONE FRAGMENT AS THE SECOND SCREW, A PLATE THAT HAD BEEN CRIMPED CAME UP FROM THE CENTRAL BONE FRAGMENT, AND IT WAS CONFIRMED THAT THE SCREW IN QUESTION WAS BROKEN AT ITS NECK. WITH THE SHAFT OF THE SCREW IN QUESTION REMAINING IN THE BONE, 4 SCREWS WERE INSERTED INTO THE CENTRAL BONE FRAGMENT AND 5 SCREWS INTO THE PERIPHERAL BONE FRAGMENT, AND THE SURGERY WAS COMPLETED WITH NO SURGICAL DELAY. THE SURGEON COMMENTED AS FOLLOWS. THE DIRECT CAUSE OF THE BREAKAGE SEEMED TO BE LOADING ON THE SCREW DUE TO THE REDUCTION. HOWEVER, EVEN WHEN A SCREW WITH A DIAMETER OF 3.5 MM WAS USED IN THE PAST SIMILAR PROCEDURES, BREAKAGE LIKE THIS TIME DID NOT OCCUR. THEREFORE, THERE IS CONCERN ABOUT A STR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15099200 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120070, K120717, K120854. One submission often covers many models, so check the product and lot details in each record.

• Z-0124-2016 · Sep 28, 2015 · Terminated
  Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile The Synthes