NA 02.231.675Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982062901), received between Jan 13, 2021 and May 16, 2023 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K110354); 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY WITH DISTAL REPLACEMENT. HARDWARE REMOVAL LEFT FEMUR DUE TO LEFT SUPRACONDYLAR/INTERCONDYLAR FEMORAL FRACTURE NONUNION, HARDWARE FAILURE AND OSTEOARTHRITIS LEFT KNEE. ON (B)(6) 2021 THE PATIENT UNDERWENT LEFT DISTAL FEMUR OPEN REDUCTION AND INTERNAL FIXATION WITH A SYNTHES LATERAL PLATE AND MULTIPLE CERCLAGE CABLES DUE TO LEFT DISTAL FEMUR COMMINUTED INTRA-ARTICULAR FRACTURE AND MORBID OBESITY. IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT HAD A FALL. SHE WAS CLIMBING OVER SOMETHING LIKE A DOG GATE, TRIPPED AND FELL. SHE INITIALLY FELT PAIN IN HER LEFT KNEE. SHE WAS DIAGNOSED WITH A LEFT DISTAL FEMUR FRACTURE. THIS COMPLAINT INVOLVES (18) DEVICES. THIS REPORT IS FOR ONE (1) 5.0MM CANNULATED VA LOCKING SCREW/75MM.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 16941038 ↗
• InjuryMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THERE WAS A HARDWARE REMOVAL/REVISION SURGERY DUE TO FEMORAL NONUNION. FROM THE LATERAL SIDE, THE SURGEON REMOVED A VA CONDYLAR PLATE AND CORRESPONDING SCREWS. FROM THE MEDIAL SIDE, THE SURGEON REMOVED A VA PROXIMAL TIBIA PLATE AND CORRESPONDING SCREWS. THE SURGEON THEN ADDRESSED THE NONUNION SITE, AND PLACED 2 NEW PLATES ONTO THE PATIENT'S FEMUR. THREE BROKEN SCREWS FROM THE PRIMARY SURGERY WERE RETAINED IN PATIENT'S FEMUR. THIS REPORT IS FOR ONE (1) 5.0MM CANNULATED VA LOCKING SCREW/75MM THIS IS REPORT 2 OF 14 FOR COMPLAINT (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16896963 ↗
• InjuryMay 9, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, THERE WAS A HARDWARE REMOVAL/REVISION SURGERY DUE TO FEMORAL NONUNION. FROM THE LATERAL SIDE, THE SURGEON REMOVED A VA CONDYLAR PLATE AND CORRESPONDING SCREWS. FROM THE MEDIAL SIDE, THE SURGEON REMOVED A VA PROXIMAL TIBIA PLATE AND CORRESPONDING SCREWS. THE SURGEON PLACED TWO NEW PLATES ONTO THE FEMUR. THREE BROKEN SCREWS FROM THE PRIMARY SURGERY WERE RETAINED IN THE PATIENT¿S FEMUR. THIS REPORT INVOLVES ONE 5.0MM CANNULATED VA LOCKING SCREW/75MM. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPLANTS. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16896372 ↗
• InjuryMay 9, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, THERE WAS A HARDWARE REMOVAL/REVISION SURGERY DUE TO FEMORAL NONUNION. FROM THE LATERAL SIDE, THE SURGEON REMOVED A VA CONDYLAR PLATE AND CORRESPONDING SCREWS. FROM THE MEDIAL SIDE, THE SURGEON REMOVED A VA PROXIMAL TIBIA PLATE AND CORRESPONDING SCREWS. THE SURGEON PLACED TWO NEW PLATES ONTO THE FEMUR. THREE BROKEN SCREWS FROM THE PRIMARY SURGERY WERE RETAINED IN THE PATIENT¿S FEMUR. THIS REPORT INVOLVES ONE 5.0MM CANNULATED VA LOCKING SCREW/75MM. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPLANTS. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16896370 ↗
• InjuryMay 9, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, THERE WAS A HARDWARE REMOVAL/REVISION SURGERY DUE TO FEMORAL NONUNION. FROM THE LATERAL SIDE, THE SURGEON REMOVED A VA CONDYLAR PLATE AND CORRESPONDING SCREWS. FROM THE MEDIAL SIDE, THE SURGEON REMOVED A VA PROXIMAL TIBIA PLATE AND CORRESPONDING SCREWS. THE SURGEON PLACED TWO NEW PLATES ONTO THE FEMUR. THREE BROKEN SCREWS FROM THE PRIMARY SURGERY WERE RETAINED IN THE PATIENT¿S FEMUR. THIS REPORT INVOLVES ONE 5.0MM CANNULATED VA LOCKING SCREW/75MM. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPLANTS. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16896368 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY WITH DISTAL REPLACEMENT. HARDWARE REMOVAL LEFT FEMUR DUE TO LEFT SUPRACONDYLAR/INTERCONDYLAR FEMORAL FRACTURE NONUNION, HARDWARE FAILURE AND OSTEOARTHRITIS LEFT KNEE. ON (B)(6) 2021 THE PATIENT UNDERWENT LEFT DISTAL FEMUR OPEN REDUCTION AND INTERNAL FIXATION WITH A SYNTHES LATERAL PLATE AND MULTIPLE CERCLAGE CABLES DUE TO LEFT DISTAL FEMUR COMMINUTED INTRA-ARTICULAR FRACTURE AND MORBID OBESITY. IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT HAD A FALL. SHE WAS CLIMBING OVER SOMETHING LIKE A DOG GATE, TRIPPED AND FELL. SHE INITIALLY FELT PAIN IN HER LEFT KNEE. SHE WAS DIAGNOSED WITH A LEFT DISTAL FEMUR FRACTURE. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR ONE (1) 5.0MM CANNULATED VA LOCKING SCREW/75MM. THIS IS REPORT 5 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 16723805 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT UNDERWENT A REMOVAL OF HARDWARE FROM DISTAL FEMUR DUE TO PAIN. THERE WAS NO SURGICAL DELAY NOTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1)5.0MM CANNULATED VA LOCKING SCREW/75MM. THIS IS REPORT 9 OF 10 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12779846 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT UNDERWENT A REMOVAL OF HARDWARE FROM DISTAL FEMUR DUE TO PAIN. THERE WAS NO SURGICAL DELAY NOTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1)5.0MM CANNULATED VA LOCKING SCREW/75MM. THIS IS REPORT 10 OF 10 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12779843 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT UNDERWENT A REMOVAL OF HARDWARE FROM DISTAL FEMUR DUE TO PAIN. THERE WAS NO SURGICAL DELAY NOTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 5.0MM CANNULATED VA LOCKING SCREW/75MM. THIS IS REPORT 2 OF 10 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12779825 ↗
• MalfunctionMar 18, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT FOR A REMOVAL SURGERY DUE TO DISTAL EPIPHYSIS FRACTURE OF THE RIGHT FEMUR. DURING THE SURGERY, TRIED TO REMOVE ALL IMPLANTED MATERIALS BUT ALL IMPLANTS HAVE NOT BEEN REMOVED FROM THE PATIENT. THE BLOCKED CANNULATED VA SCREW OF 5.0 L 75 MM WAS POSITIONED AT AN ANGLE GREATER THAN FIFTEEN DEGREES PROXIMALLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WERE NO FRAGMENTS ARE GENERATED. THERE WERE NO PATIENT CONSEQUENCES. CONCOMITANT DEVICES REPORTED: CORTICAL SCREWS (PART# 214.834; LOT# 47P9061; QUANTITY: 2), CORTICAL SCREWS (PART# 214.834; LOT# L814671; QUANTITY: 1), CORTICAL SCREWS (PART# 214.842; LOT# 76P1595; QUANTITY: 1), CORTICAL SCREWS (PART# 214.844; LOT# L812151; QUANTITY: 2), 5.0 CANNULATED VA LCK SCRW/70 (PART# 02.231.670; LOT# L498011; QUANTITY: 2), VA-LCP CONDYLAR PLATE 4.5/5.0 (PART# 02.124.407; LOT# 48P0003; QUANTITY: 1), CANN-LOCKSCR ¿5 L70 SST (PART# 02.205.070; LOT# 62P4598; QUANTITY: 1). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) 5.0MM CANNULATED VA LOCKING SCREW/75MM. THIS REPORT IS 1 OF 3 PC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11520133 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REMOVAL AND REVISION OF HARDWARE DUE TO FALL. NO FRAGMENTS GENERATED. NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ELEVEN (11) DEVICES. THIS REPORT IS FOR (1) 5.0MM CANNULATED VA LOCKING SCREW/75MM. THIS REPORT IS 2 OF 10 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11165075 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110354. One submission often covers many models, so check the product and lot details in each record.

• Z-1125-2014 · Feb 5, 2014 · Terminated
  Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plat
• Z-0401-2014 · May 29, 2013 · Terminated
  Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fra