VA-LCP 03.231.005Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10886982077325), received between Sep 22, 2017 and Apr 7, 2026 — classified as 4 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (34 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 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT AIMING ARM WAS DISCONNECTING FROM PLATE. REAMER WAS TOO DULL AND KEPT GETTING INCARCERATED IN THE BONE. SURGERY DELAYED DUE TO THE REPORTED EVENT. PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24802661 ↗
• MalfunctionApr 7, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT AIMING ARM WAS DISCONNECTING FROM PLATE. REAMER WAS TOO DULL AND KEPT GETTING INCARCERATED IN THE BONE. SURGERY DELAYED DUE TO THE REPORTED EVENT. PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24802653 ↗
• MalfunctionAug 25, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A SURGERY TO TREAT A PERIPROSTHETIC DISTAL FEMUR FRACTURE, SURGEON MADE A LATERAL INCISION ON THE LATERAL ASPECT OF THE DISTAL FEMUR, REDUCED THE FRACTURE AND HELD THE REDUCTION WITH 2 X 2.5MM K-WIRES. STAFF OPENED AN 18 HOLE VA-LCP CURVE CONDYLAR PLATE. THE SCRUB NURSE ATTACHED THE CONNECTION BOLT FOR THE AIMING ARM TO THE PLATE FINGER TIGHT AND TIGHTEN THE NUT FOR THE CONNECTION BOLT, ALSO FINGER TIGHT. THE SURGEON THEN CHECKED THE ALIGNMENT AND TIGHTEN THE BOLT AND NUT WITH THE SPANNER. AT THIS POINT, THE CONNECTION BOLT CAME AWAY FROM THE PLATE. THE SURGEON RECONNECTED THE CONNECTION BOLT TO THE PLATE, BUT WAS STRUGGLING TO GET THE SAME INITIAL SECURE CONNECTION. STAFF CHANGED TO THE SPARE CONNECTION BOLT IN THE SET TO SEE IF THAT WAS BETTER. SURGEON MANAGED TO GET A RELATIVELY SECURE CONNECTION AND WENT TO INSERT THE PLATE, AT THIS POINT THE PLATE FELL OFF THE AIMING ARM AND FELL ON THE FLOOR. STAFF QUICKLY CHANGED TO A 16 HOLE PLATE AND PROCEEDED WITH THE SURGERY WITHOUT INCIDENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22889546 ↗
• MalfunctionAug 25, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A SURGERY TO TREAT A PERIPROSTHETIC DISTAL FEMUR FRACTURE, SURGEON MADE A LATERAL INCISION ON THE LATERAL ASPECT OF THE DISTAL FEMUR, REDUCED THE FRACTURE AND HELD THE REDUCTION WITH 2 X 2.5MM K-WIRES. STAFF OPENED AN 18 HOLE VA-LCP CURVE CONDYLAR PLATE. THE SCRUB NURSE ATTACHED THE CONNECTION BOLT FOR THE AIMING ARM TO THE PLATE FINGER TIGHT AND TIGHTEN THE NUT FOR THE CONNECTION BOLT, ALSO FINGER TIGHT. THE SURGEON THEN CHECKED THE ALIGNMENT AND TIGHTEN THE BOLT AND NUT WITH THE SPANNER. AT THIS POINT, THE CONNECTION BOLT CAME AWAY FROM THE PLATE. THE SURGEON RECONNECTED THE CONNECTION BOLT TO THE PLATE, BUT WAS STRUGGLING TO GET THE SAME INITIAL SECURE CONNECTION. STAFF CHANGED TO THE SPARE CONNECTION BOLT IN THE SET TO SEE IF THAT WAS BETTER. SURGEON MANAGED TO GET A RELATIVELY SECURE CONNECTION AND WENT TO INSERT THE PLATE, AT THIS POINT THE PLATE FELL OFF THE AIMING ARM AND FELL ON THE FLOOR. STAFF QUICKLY CHANGED TO A 16 HOLE PLATE AND PROCEEDED WITH THE SURGERY WITHOUT INCIDENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22889525 ↗
• MalfunctionJul 22, 2025Device-Device Incompatibility; Device-Device Incompatibility

  I WAS AT (B)(6) HOSPITAL TODAY AND THIS INSTRUMENT KEEPS DISENGAGING WITH THE VA CONDYLAR JIG. 03.231.005 NO HARM CAUSED, NO FURTHER DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22564862 ↗
• MalfunctionJun 11, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025 THE THREADS ON BOLT WERE STRUGGLING TO ENGAGE WITH PLATES PROPERLY. PRESUMABLY DUE TO WEAR OVER YEARS OF USE. WHILE TRYING TO ATTACH BOLT TO DISTAL FEMUR PLATE THE FIT WASN¿T SECURE AND DAMAGED THE THREADS IN THE PLATE. THE PLATE COULD NO LONGER BE USED WITH AN AIMING ARM, SO ANOTHER TRAY NEEDED TO BE OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22183929 ↗
• MalfunctionMay 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE AIMING ARM FOR 4.5 VA CURVED CONDYLAR SET WAS NOT LINING UP WITH THE PLATE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22066326 ↗
• MalfunctionMay 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED WHEN PLACING THE 14-HOLE PLATE INSIDE THE PATIENT, THE JIG CAME OFF THE PLATE. IT WAS UNABLE TO BE REATTACHED TO THE 14-HOLE PLATE, SO IT WAS TRIED ON A 16-HOLE PLATE. THE THREADS ON THAT PLATE WERE DAMAGED AFTER A COUPLE OF ATTEMPTS SO WAS NOT USED. THE 14-HOLE PLATE WAS IMPLANTED WITHOUT THE USE OF THE JIG. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TWENTY-TO-THIRTY-MINUTE DELAY AND NO PATIENT CONSEQUENCES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22041102 ↗
• MalfunctionMay 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED WHEN PLACING THE 14-HOLE PLATE INSIDE THE PATIENT, THE JIG CAME OFF THE PLATE. IT WAS UNABLE TO BE REATTACHED TO THE 14-HOLE PLATE, SO IT WAS TRIED ON A 16-HOLE PLATE. THE THREADS ON THAT PLATE WERE DAMAGED AFTER A COUPLE OF ATTEMPTS SO WAS NOT USED. THE 14-HOLE PLATE WAS IMPLANTED WITHOUT THE USE OF THE JIG. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TWENTY-TO-THIRTY-MINUTE DELAY AND NO PATIENT CONSEQUENCES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22041101 ↗
• MalfunctionApr 9, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS AN ISSUE ATTACHING THE INSERTION HANDLE TO A VA LCP¿ CURVED CONDYLAR PLATE (4.5 MM) WITH THE LOCKING BOLT FOR AIMING ARM. FOR SOME REASON THE LOCKING BOLT KEPT DISENGAGING FROM THE PLATE. SURGEON ENDED UP OPENING A SPARE LOCKING BOLT AND THE OPERATION WENT WELL. THERE WAS A 4 MINUTES OF SURGICAL DELAY DUE TO THE REPORTED EVENT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21808156 ↗
• MalfunctionApr 2, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE YELLOW STRIPED CONNECTING SCREW DID NOT THREAD TIGHTLY ONTO THE VA CONDYLAR PLATE. IT WAS THOUGHT THAT THE SCREW MUST BE STRIPPED. IT WOULDN'T THREAD INTO ANY PLATE. THE ISSUE HAD OCCURRED WITH THE SURGEON THREE TIMES. DURING SURGERY ON (B)(6) 2025, THERE WAS A 45-MINUTE SURGICAL DELAY IN RELATION TO THE EVENT. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21754504 ↗
• MalfunctionApr 2, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE YELLOW STRIPED CONNECTING SCREW DID NOT THREAD TIGHTLY ONTO THE VA CONDYLAR PLATE. IT WAS THOUGHT THAT THE SCREW MUST BE STRIPPED. IT WOULDN'T THREAD INTO ANY PLATE. THE ISSUE HAD OCCURRED WITH THE SURGEON THREE TIMES. DURING SURGERY ON (B)(6) 2025, THERE WAS A 45-MINUTE SURGICAL DELAY IN RELATION TO THE EVENT. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21754495 ↗
• MalfunctionMar 26, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2025 THAT THE YELLOW STRIPED CONNECTING SCREW DID NOT THREAD TIGHTLY ONTO THE VA CONDYLAR PLATE. THE SCREW MUST BE STRIPPED. IT STRIPPED THE LOCKING HOLE ON THE RIGHT 16 HOLE CURVED VA CONDYLAR PLATE. IT WON¿T THREAD INTO ANY PLATE. SURGEON WANTED EVERYTHING EXCHANGED. ACTION TAKEN INCLUDE TAKING THE AIMING ARM OFF AND CUTTING THE LEG OPEN TO SEE THE PLATE. IT¿S THE 2ND TIME THE BOLT CAME OFF THE PLATE. THERE WERE A SURGICAL DELAY OF 45 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21698136 ↗
• InjuryMar 26, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED ON (B)(6) 2025, THAT THE YELLOW STRIPED CONNECTING SCREW DID NOT THREAD TIGHTLY ONTO THE VA CONDYLAR PLATE. THE SCREW MUST BE STRIPPED. IT STRIPPED THE LOCKING HOLE ON THE RIGHT 16 HOLE CURVED VA CONDYLAR PLATE. IT WON'T THREAD INTO ANY PLATE. SURGEON WANTED EVERYTHING EXCHANGED. ACTION TAKEN INCLUDE TAKING THE AIMING ARM OFF AND CUTTING THE LEG OPEN TO SEE THE PLATE. IT¿S THE 2ND TIME THE BOLT CAME OFF THE PLATE. THERE WERE A SURGICAL DELAY OF 45 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21698042 ↗
• MalfunctionMar 26, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED ON (B)(6) 2025 THE CONNECTING SCREW WAS STRIPPED ON THE BOTTOM. THIS WAS IMPACTING THREAD ON THREAD CONNECTION BETWEEN THE SCREW AND PLATE AND NEEDED TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697212 ↗
• MalfunctionFeb 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A NAIL PLATE COMBO, VA CONDYLAR AIMING ARM WAS USED. THE CORTICAL SCREW MISSED THE PLATE. THERE WAS A DELAY IN SURGERY DUE TO HAVING TO FREEHAND. THERE WAS 3 MINUTES OF SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) INTERLCKNG BOLT 4.5 VA COND INSERTN HNDL THIS IS REPORT 7 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18785284 ↗
• MalfunctionFeb 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A NAIL PLATE COMBO, VA CONDYLAR AIMING ARM WAS USED. THE CORTICAL SCREW MISSED THE PLATE. THERE WAS A DELAY IN SURGERY DUE TO HAVING TO FREEHAND. THERE WAS 3 MINUTES OF SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) INTERLCKNG BOLT 4.5 VA COND INSERTN HNDL. THIS IS REPORT 3 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18785276 ↗
• MalfunctionSep 21, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023, WHEN ASSEMBLING THE AIMING ARM TO ATTACH THE VA-LCP CURVED CONDYLAR PLATE, THE CONNECTING SCREW WAS NOT THREADING INTO THE HOLE IN THE PLATE TO ATTACH THE AIMING ARM. WHEN FURTHER EXAMINED, BOTH THE HOLE IN THE PLATE AND THE THREADED PART OF THE SCREW WERE DAMAGED. THE SURGEON HAD TO FREE HAND THE REST OF THE CASE WITHOUT THE AIMING ARM. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 15-MINUTE DELAY. THIS REPORT INVOLVES ONE INTERLOCKING BOLT FOR 4.5MM VA-LCP CONDYLAR INSERTN HANDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17787292 ↗
• MalfunctionMay 23, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE INTERLOCKING BOLT FOR 4.5 VA-LCP CURVED CONDYLAR PLATE INSERTION HANDLE (03.231.005) GOT A DEFECT AT THE DISTAL THREAD. ACCORDING TO THE REPORT, THIS DEFECT CAUSED A CROSS THREAD IN THE VA-LCP CURVED CONDYLAR PLATE (02.124.415) DURING INSERTION OF THE INTERLOCKING BOLT HANDLE IN THE PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14470077 ↗
• MalfunctionMar 26, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022, WHILE PERFORMING A DISTAL FEMUR FRACTURE, THE INTERLOCKING BOLT STRIPPED OUT AND WOULD NOT ALLOW THE HANDLE TO BE ATTACHED TO THE PLATE. A SEPARATE INTERLOCKING BOLT WAS USED, AND THE SURGERY PROCEEDED. THERE WAS A SURGICAL DELAY OF 5 MINUTES. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) INTERLCKNG BOLT 4.5 VA COND INSERTN HNDL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13915470 ↗
• MalfunctionJan 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS FURTHER REPORTED THAT THE ISSUE WAS DISCOVERED WHILE TRYING TO ATTACH TO THE JIG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13254406 ↗
• MalfunctionJan 10, 2022Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE UNKNOWN VARIABLE ANGLE CONDYLAR AIMING ARM, THE THREADED GUIDE THAT LOCKED THE AIMING ARM INTO THE PLATE WERE STRIPPED. THOUGHT ABOUT THIS AFTER THE FACT. IT'S TWO (2) OF THEM AND THE THREAD IS STRIPPED SO DIDN'T ENGAGE THE PLATE. THERE WAS NO SURGERY DATE AND NO PATIENT TO IDENTIFY WITH. THERE WAS NO PATIENT WERE IDENTIFIED BECAUSE IT DID NOT FIND TO SOLVE THE CASE. THERE WAS NO KNOWN HOSPITAL OR PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNK - GUIDES/SLEEVES/AIMING: AIMING ARM (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN); UNK - PLATES: 4.5MM VA LCP CONDYLAR PLATE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) INTERLCKNG BOLT 4.5 VA COND INSERTN HNDL. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13214786 ↗
• MalfunctionJan 10, 2022Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE UNKNOWN VARIABLE ANGLE CONDYLAR AIMING ARM, THE THREADED GUIDE THAT LOCKED THE AIMING ARM INTO THE PLATE WERE STRIPPED. THOUGHT ABOUT THIS AFTER THE FACT. IT'S TWO (2) OF THEM AND THE THREAD IS STRIPPED SO DIDN'T ENGAGE THE PLATE. THERE WAS NO SURGERY DATE AND NO PATIENT TO IDENTIFY WITH. THERE WAS NO PATIENT WERE IDENTIFIED BECAUSE IT DID NOT FIND TO SOLVE THE CASE. THERE WAS NO KNOWN HOSPITAL OR PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNK - GUIDES/SLEEVES/AIMING: AIMING ARM (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN); UNK - PLATES: 4.5MM VA LCP CONDYLAR PLATE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) INTERLCKNG BOLT 4.5 VA COND INSERTN HNDL. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13214666 ↗
• MalfunctionNov 17, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INTERLOCKING BOLT WAS UNABLE TO ATTACH TO THE AIMING ARM AS THE THREADS WOULD NOT ENGAGE. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) INTERLOCKING BOLT FOR 4.5MM VA-LCP CONDYLAR INSERTN HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12828776 ↗
• MalfunctionSep 24, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT, WHEN THE CURVED CONDYLAR PLATE AND THE AIMING ARM WAS ATTACHED, IT WAS NOT ABLE TO ATTACH DUE TO THE STRIPPAGE OF THE SCREW HOLE OF THE PLATE. WHILE USING THE AIMING ARM ON THE NEW UNKNOWN PLATE, THE NEUTRAL SLEEVES WERE NOT CONNECTING TO THE HARPOON. THE PEDIATRIC AIMING ARM WAS OUTRIGGER. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH TEN(10) MINUTES DELAY. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) INTERLCKNG BOLT 4.5 VA COND INSERTN HNDL. THIS IS REPORT 3 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12525854 ↗

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