NA 02.231.680Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982062918), received between Mar 9, 2018 and Apr 14, 2023 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2023Adverse 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 HAD A FALL AND SUSTAINED A PERIPROSTHETIC FEMUR FRACTURE REQUIRING OPEN REDUCTION INTERNAL FIXATION (ORIF). THE PLATE AND SCREWS WERE MANUFACTURED BY SYNTHES. IMPLANTS DID NOT APPEAR TO BE REMOVED. ON (B)(6) 2021 X-RAY TAKEN SHOWED PERSISTENT DISPLACEMENT OF A PARTIALLY HEALED DISTAL FEMUR FRACTURE WITH LATERAL PLATE AND SCREW CONSTRUCT STABLE IN POSITION. ON (B)(6) 2021 INJECTION TO LEFT KNEE FOR PAIN PERFORMED. PAIN HAS PERSISTED DESPITE PHYSICAL THERAPY, BRACING, AND NERVE BLOCKS. ON (B)(6) 2021: SURGEON STATEED THAT THE LEFT KNEE IS LIGAMENTOUSLY LOOSE TO VARUS STRESS AND PAIN ON (B)(6) 2021 X-RAY RESULTS STATED THAT THERE IS A PERIPROSTHETIC FRACTURE IN THE DISTAL FEMORAL DIAPHYSIS THAT IS SUBACUTE TO CHRONIC. THERE IS ONE SHAFT WIDTH POSTERIOR DISPLACEMENT OF THE DISTAL FRACTURE FRAGMENT. THERE IS NO EVIDENCE OF HARDWARE FRACTURE OR LOOSENING. SURGEON STATES LEFT KNEE IS UNSTABLE LIKELY SECONDARY TO MALUNION OF THE FEMUR FRACTURE WITH RESULTANT SHORTENING. ON (B)(6) 2021: PATIENT SUSTAINED TWO FALLS RESULTING IN A PELVIC AND THEN A RIGHT HUMERAL FRACTURE. MEDICAL RECORDS DO NOT INCLUDE THE PRIMARY OPERATIVE NOTES, NOR THE REVISI

  Patient problems: Bone Fracture(s); Malunion of Bone; Pain

  MAUDE report 16747878 ↗
• InjuryJul 23, 2020Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THAT THE PATIENT UNDERWENT THE REMOVAL OF OSTEOSYNTHESIS MATERIAL AND A CONDYLAR SUPPORT PLATE THAT HAD FAILED. THE DISTAL LOCKING SCREWS OF THE PLATE WERE LOOSE AND ONE WAS ALREADY EXPOSED OUTSIDE OF THE SKIN. AN ADDITIONAL REDUCTION WAS PERFORMED BUT THE SCREWS DID NOT BLOCK THE PLATE AND IT WAS DECIDED TO REMOVE ALL THE MATERIAL AND PUT A SPLINT IN ONE OF THE WOUNDS THAT WAS FOUND TO BE INFECTED. THE FIRST INTERVENTION WAS PERFORMED BECAUSE THE DISTAL SCREWS OF THE PLATE CAME OFF. THE SECOND OPERATION WAS PERFORMED TO EXTRACT A SCREW THAT WAS EXPOSED THROUGH THE SKIN AND THE THIRD INTERVENTION WAS WHEN ALL OF THE MATERIAL WAS REMOVED. THE FIRST TWO INTERVENTIONS WERE PERFORMED TO REMOVE THE IMPLANT AND TRY TO CORRECT THE NEW FRACTURE, IN THE LAST SURGERY IT WAS SHOWN THAT THERE WAS AN INFECTION. THIS REPORT IS FOR ONE (1) 5.0MM CANNULATED VA LOCKING SCREW/80MM. THIS IS REPORT 9 OF 9 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10314634 ↗
• InjuryJul 23, 2020Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THAT THE PATIENT UNDERWENT THE REMOVAL OF OSTEOSYNTHESIS MATERIAL AND A CONDYLAR SUPPORT PLATE THAT HAD FAILED. THE DISTAL LOCKING SCREWS OF THE PLATE WERE LOOSE AND ONE WAS ALREADY EXPOSED OUTSIDE OF THE SKIN. AN ADDITIONAL REDUCTION WAS PERFORMED BUT THE SCREWS DID NOT BLOCK THE PLATE AND IT WAS DECIDED TO REMOVE ALL THE MATERIAL AND PUT A SPLINT IN ONE OF THE WOUNDS THAT WAS FOUND TO BE INFECTED. THE FIRST INTERVENTION WAS PERFORMED BECAUSE THE DISTAL SCREWS OF THE PLATE CAME OFF. THE SECOND OPERATION WAS PERFORMED TO EXTRACT A SCREW THAT WAS EXPOSED THROUGH THE SKIN AND THE THIRD INTERVENTION WAS WHEN ALL OF THE MATERIAL WAS REMOVED. THE FIRST TWO INTERVENTIONS WERE PERFORMED TO REMOVE THE IMPLANT AND TRY TO CORRECT THE NEW FRACTURE, IN THE LAST SURGERY IT WAS SHOWN THAT THERE WAS AN INFECTION. THIS REPORT IS FOR ONE (1) 5.0MM CANNULATED VA LOCKING SCREW/80MM. THIS IS REPORT 8 OF 9 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10314534 ↗
• MalfunctionMay 20, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 5.0MM CANNULATED VA LOCKING SCREW/80MM PACKAGE WAS RECEIVED EMPTY. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 5.0MM CANNULATED VA LOCKING SCREW/80MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10074545 ↗
• MalfunctionMay 20, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 5.0MM CANNULATED VA LOCKING SCREW/80MM PACKAGE WAS RECEIVED EMPTY. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES 3 DEVICES. THIS REPORT IS FOR 1 5.0MM CANNULATED VA LOCKING SCREW/80MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10074541 ↗
• MalfunctionMay 20, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 5.0MM CANNULATED VA LOCKING SCREW/80MM PACKAGE WAS RECEIVED EMPTY. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES 3 DEVICES. THIS REPORT IS FOR 1 5.0MM CANNULATED VA LOCKING SCREW/80MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10074540 ↗
• MalfunctionFeb 27, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON NOTED THAT THE CANNULATED VARIABLE LOCKING SCREW DID NOT LOCK INTO DISTAL HOLE AND THE SURGEON ALSO MENTIONED IT MAY HAVE STRIPPED THE THREADS ON THE VARIABLE ANGLE- LOCKING CONDYLAR PLATE DURING SCREW INSERTION. FRAGMENTS WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR A CANNULATED VARIABLE LOCKING SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8374731 ↗
• InjuryMar 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER QUALITY UNIT RECEIVED A MAUDE REPORT FORWARDED FROM DEPARTMENT OF HUMAN SERVICES; THIS REPORT IS AGAINST USER FACILITY REPORT MW5074624. ONLY ADDITIONAL AND/OR CORRECTED INFORMATION WILL BE CONTAINED IN THIS REPORT. A COPY OF THE MAUDE EVENT REPORT IS ATTACHED. IT WAS REPORTED THAT ON AN UNKNOWN DATE APPROXIMATELY THREE YEARS AGO, PATIENT WAS IMPLANTED WITH ONE (1) UNKNOWN TOTAL KNEE ARTHROPLASTY (TKA) CONSTRUCT (MANUFACTURER UNKNOWN). ON (B)(6) 2016, PATIENT UNDERWENT IMPLANT PROCEDURE TO TREAT LOSS STRESS FEMUR FRACTURE. PATIENT WAS IMPLANTED WITH ONE 4.5 MM (1) VARIABLE ANGLE (VA) CURVED CONDYLAR PLATE, EIGHT (8) 5.0 MM VA LOCKING SCREWS, ONE (1) 5.0 MM CANNULATED VA LOCKING SCREW, ONE (1) 4.5 MM CORTEX SCREW. SUBSEQUENTLY, ON AN UNKNOWN DATE, JUST FIFTY-ONE (51) DAYS AFTER THE PATIENT BEING RELEASED TO A FULL WEIGHT BEARING STATUS, THE PLATE BROKE AND THE PATIENT DEVELOPED A NONUNION AND THE BONE HAD RE FRACTURED. ON (B)(6) 2017, PATIENT UNDERWENT REVISION SURGERY. THE SURGEON WENT INTO SURGERY WITH THE PLAN TO NOT REMOVE THE IMPLANTS, BUT SUBSEQUENTLY, ENDED UP REMOVING ALL IMPLANTS. THE SURGEON CUT OUT THE TISSUE SURROUNDING THE PLATE AND THE PLATE WAS STILL STUCK. S

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 7327948 ↗

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