NA 04.118.518Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982108821), received between Jul 22, 2022 and Jul 9, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6), 2025, THE PATIENT UNDERWENT ORIF SURGERY FOR CLAVICLE SHAFT FRACTURE WITH THE LOW-PROFILE METAPHYSEAL SCREW. IN THE SURGERY, A CLAVICLE PLATE 2.7 (RIGHT DIAPHYSIS) WAS USED IN A YOUNG PATIENT AND FIXED WITH CORTICAL SCREWS AND LOW-PROFILE METAPHYSEAL SCREW IN QUESTION. WHILE THE SURGEON WAS TIGHTENING THE ENTIRE SCREW, THE HEAD OF THE LOW-PROFILE METAPHYSEAL SCREW IN QUESTION BROKE OFF. THEREFORE, THE SURGEON REMOVED ALL THE SCREWS, REMOVED THE SCREW SHAFT FROM THE BODY, AND REPOSITIONED THE PLATE. THE IMPLANT WAS THEN PLACED AGAIN. THE SURGERY WAS EXTENDED BY 30 MINUTES AND COMPLETED IN TOTAL IN 2 HOURS. THE SURGEON MENTIONED THAT THE DIRECTION THE SLEEVE MAY HAVE BEEN SLIGHTLY DIFFERENTLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459453 ↗
• MalfunctionNov 14, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT OPEN FRACTURE SURGERY FOR CLAVICLE FRACTURE WITH VA CLAVICLE PLATE AND THE SCREW IN QUESTION. IN THE SURGERY, A LOW-PROFILE METAPHYSIAL SCREW BROKE DURING THE SURGERY, REQUIRING A REMOVAL PROCEDURE, WHICH EXTENDED THE SURGERY TIME. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20684414 ↗
• MalfunctionJun 6, 2023Break; Break

  DEVICE REPORT FROM SWITZERLAND REPORTS, AN EVENT AS FOLLOWS: IT WAS REPORTED, THAT DURING A PROCEDURE ON (B)(6) 2023. A 2.7 METAPHYSEAL SCREW BROKE WHILE BEING SCREWING INTO THE BONE (CLAVICLE). THE HEAD OF THE SCREW SNAPPED OFF AFTER APPLYING MODERATE FORCE, AND IN COMBINATION WITH A VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) CLAVICLE HOOK PLATE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 2.7MM TI METAPHYSEAL SCR/SLF- TPNG W/T8 STRDRV RECESS/18MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17075058 ↗
• MalfunctionJul 22, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT AN OPEN REDUCTION WITH INTERNAL FIXATION FOR FRACTURE OF SHAFT OF CLAVICLE. WHEN THE SURGEON INSERTED THE 2ND SCREW TO A HOLE OF A PLATE, THE SCREW BROKE AT ITS NECK. THE SURGEON REMOVED THE PLATE, TRIED TO EXTRACT THE SCREW SHAFT LEFT IN THE BONE WITH RADIO PLIERS, ETC., BUT HE COULDN¿T. THE SALES REP PROPOSED TO EXTRACT IT BY SHAVING THE BONE AROUND THE SCREW SHAFT WITH A CANULATED DRILL, AND THE SURGEON COULD FINALLY EXTRACT THE SCREW SHAFT. SINCE THE EXTRACTION OF THE SCREW SHAFT MADE A BIG HOLE ON THE BONE, THE SURGEON TRIED TO USE ANOTHER PLATE, BUT THE PLATE DID NOT FIT TO THE BONE DUE TO SHAPE MISMATCH WITH THE BONE. THE SURGEON DECIDED TO USE THE ORIGINAL PLATE FOR THE TREATMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 90 MINUTES DELAY. IT WAS NOTED THE PATIENT HAD HARD BONES. THERE ARE NO PIECES IN THE PATIENT. THE SURGEON CONFIRMED BY X-RAY. PATIENT IS LISTED AS STABLE. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR A SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15085296 ↗
• MalfunctionJul 22, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR FRACTURE OF SHAFT OF CLAVICLE. WHEN THE SURGEON STARTED INSERTING THE 2ND SCREW, THE HEAD OF THE 1ST SCREW INSERTED PREVIOUSLY JUMPED UP AND BROKE AT ITS NECK. SINCE THE SHAFT OF THE SCREW WAS LEFT IN THE BONE, THE SURGEON SHAVED THE BONE AROUND THE SHAFT OF THE SCREW WITH A COMPETITOR¿S SCALPEL AND EXTRACTED THE SCREW SHAFT BY RADIO PLIERS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THERE ARE NO PIECES REMAINING IN THE PATIENT. THE SURGEON CONFIRMED BY X-RAY. CONCOMITANT DEVICE REPORTED: UNK - INSERTION INSTRUMENTS: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR A SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15084379 ↗

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