VA-LCP 02.117.901Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982037480), received between Mar 16, 2018 and Oct 21, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

1 other recall cover devices cleared under the same FDA submission (K120070); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE, THE SURGEON WAS PLACING A VARIABLE ANGLE LOCKING COMPRESSION PLATE MEDIAL DISTAL HUMERUS PLATE 2 HOLE MEDIUM AND VARIABLE ANGLE LOCKING COMPRESSION PLATE LATERAL DISTAL HUMERUS PLATE 1 HOLE SHORT. THE SURGEON USED A CONDYLE AND WAS SHOOTING IN THE SCREW, TRYING TO CATCH THE DISTAL LOCK BUT IT WOULD NOT LOCK. THE SURGEON PULLED IT OUT AND ATTEMPTED TO USE ANOTHER SCREW BUT THAT SCREW WOULD NOT WORK EITHER. THE SURGEON LEFT THE SCREW IN THE PLATE UNLOCKED. AT THAT POINT IT BEHAVES AS A COMPRESSION SCREW. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 2.7MM/3.5MM VA-LCP LAT DISTAL HUMERUS PL 1H/LT/69MM-SHORT. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10715091 ↗
• MalfunctionJul 10, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018. THE 2.7 VARIABLE ANGLE (VA) LOCKING SCREW DID NOT LOCK INTO THE SYNTHES 2.7/3.5 VA LOCKING COMPRESSION PLATE (LCP) LATERAL DISTAL HUMERUS PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH NO SURGICAL DELAY. THERE WAS NO REPORTED PATIENT CONSEQUENCE. THIS REPORT IS FOR A 2.7MM/3.5MM VA-LCP LAT DISTAL HUMERUS PLATE 1H/LT/69MM-SHORT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7674165 ↗
• MalfunctionMar 16, 2018Peeled/Delaminated; Failure to Align; Peeled/Delaminated; Failure to Align

  IT WAS REPORTED DURING OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A DISTAL HUMERUS FRACTURE (INITIAL SURGERY) ON (B)(6) 2018, THE TWO DISTAL LOCKING HOLES ON A VARIABLE ANGLE LOCKING COMPRESSION (VA-LCP) DISTAL PLATE WERE STRIPPED AND WILL NOT ACCEPT ANY LOCKING SCREWS. THE 2 DISTAL LOCKING SCREWS DID NOT HAVE ANY VISIBLE MALFUNCTION ON THEM. SURGEON OPTED TO USE VA-LCP DISTAL PLATE AND 2 DISTAL LOCKING SCREWS FROM ANOTHER SET WHICH WAS EASILY ACCESSIBLE IN ORDER TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY NOR ANY IMPACT TO PATIENT. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. CONCOMITANT PARTS REPORTED: PRODUCT CODE: 2.7 MM LOCKING SCR,14 MM LOT # :UNKNOWN. PRODUCT CODE: 2.7 MM LOCKING SCR 16 MM LOT # :UNKNOWN. PRODUCT CODE: 2.7 NON-LCKNG SCR, 26 MM LOT # :UNKNOWN. PRODUCT CODE: 2.7 MM LOCKING SCR, 28 MM LOT # :UNKNOWN. PRODUCT CODE: 2.7 MM LOCKING SCR, 30 MM LOT # :UNKNOWN. PRODUCT CODE: 2.7 MM LOCKING SCR,32 MM LOT # :UNKNOWN. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7345969 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120070. 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