VA-LCP 03.127.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982075109), received between Feb 5, 2018 and Aug 4, 2025 — classified as 3 injuries, 7 malfunctions.

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

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT WHILE INSPECTING THE INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS, REP NOTICED THAT THERE WERE SOME THAT WERE DAMAGED. REP DOES NOT KNOW WHEN THIS DAMAGE OCCURRED WHETHER IT WAS POSTOP OR PREOP. THERE WAS NO PATIENT INVOLVEMENT. SOME OF THE INSTRUMENTS HAVE TO BE ABLE TO SEND BACK, BUT THERE ARE A COUPLE THAT WILL NOT BE ABLE TO RETURN BECAUSE THEY WERE DISPOSED OF BY THE FACILITY. REP KNOWS THE LOT NUMBER ON SOME OF THEM, BUT THE ONES THAT WERE DISPOSED OF REP DOES NOT KNOW THE LOT NUMBER. 1. PRODUCT # 314.118, LOT # H887026, QUANTITY 1. THIS ITEM IS A T25 SCREWDRIVER, AND THE TIP OF THE SCREWDRIVER IS STRIPPED. THIS ITEM IS AVAILABLE FOR RETURN. 2. PRODUCT # 03.127.010, LOT # 8391544, QUANTITY 1. THIS ITEM IS A DRILL SLEEVE FOR AN AIMING ARM, AND THE TIP OF IT IS BENT AND NEEDS REPLACED. THIS ITEM IS AVAILABLE FOR RETURN. 3. PRODUCT # 319.006, LOT # H873105, QUANTITY 1. THIS ITEM IS A DEPTH GAUGE, AND THE TIP OF THE DEPTH GAUGE IS BROKE OFF. THIS ITEM IS AVAILABLE FOR RETURN. 4. PRODUCT.# 03.333.301, LOT # UNKNOWN, QUANTITY 2. THESE TWO ITEMS ARE POWER SHAFTS T6 AND THE TIPS OF THEM WERE STRIPPED. THESE ITEMS ARE NOT AVAILABLE FOR RETURN DUE TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709621 ↗
• MalfunctionJun 4, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING LOAN KIT INSPECTION ON AN UNKNOWN DATE IN 2024, THE GUIDE SLEEVE WAS BENT FROM THE TOP. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. THIS REPORT IS FOR A LCKNG/NEUTRAL GUIDE FOR 3.5MM VA-LCP PROX TIBIA AIMING ARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19461476 ↗
• MalfunctionNov 30, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON NOVEMBER 10, 2023, THE INSTRUMENT BENT AND BECAME UNUSABLE. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE LCKNG/NEUTRAL GUIDE FOR 3.5MM VA-LCP PROX TIBIA AIMING ARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18237159 ↗
• MalfunctionSep 14, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THAT THERE WAS A SCREW COLD WELDED INTO THE NEUTRAL GUIDE AND DRILL BIT STUCK IN THE DRILL GUIDE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS/ OUTCOME: SUCCESSFUL. THIS REPORT IS FOR ONE (1) LCKNG/NEUTRL GUIDE 3.5 VA PRX TIB AM ARM. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17747745 ↗
• MalfunctionAug 10, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SET INSPECTION ON (B)(6) 2018, IT WAS NOTICED THAT THE TIP OF THREE (3) LOCKING/NEUTRAL GUIDES FOR 3.5 MM VARIABLE ANGLE-PERIARTICULAR PLATING PROXIMAL TIBIA AIMING ARM WAS DEFORMED AND BOTTOM WAS DAMAGED. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. DURING MANUFACTURER¿S INVESTIGATION OF THE RETURNED DEVICE IT WAS OBSERVED THAT APPROXIMATELY 10% OF THE CIRCUMFERENCE OF THE DISTAL END OF THE LOCKING/NEUTRAL GUIDE WAS DEFORMED/ BENT. THIS PRODUCT CONDITION WAS REEVALUATED AND DETERMINED TO BE REPORTABLE ON AUGUST 6, 2018. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7773546 ↗
• MalfunctionAug 10, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SET INSPECTION ON (B)(6) 2018, IT WAS NOTICED THAT THE TIP OF THREE (3) LOCKING/NEUTRAL GUIDES FOR 3.5 MM VARIABLE ANGLE-PERIARTICULAR PLATING PROXIMAL TIBIA AIMING ARM WAS DEFORMED AND BOTTOM WAS DAMAGED. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. DURING MANUFACTURER¿S INVESTIGATION OF THE RETURNED DEVICE IT WAS OBSERVED THAT APPROXIMATELY 45% OF THE CIRCUMFERENCE OF THE DISTAL END OF THE LOCKING/NEUTRAL GUIDE WAS DEFORMED/ BENT. THIS PRODUCT CONDITION WAS REEVALUATED AND DETERMINED TO BE REPORTABLE ON (B)(6) 2018. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7773494 ↗
• MalfunctionAug 10, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SET INSPECTION ON (B)(6) 2018, IT WAS NOTICED THAT THE TIP OF THREE (3) LOCKING/NEUTRAL GUIDES FOR 3.5 MM VARIABLE ANGLE-PERIARTICULAR PLATING PROXIMAL TIBIA AIMING ARM WAS DEFORMED AND BOTTOM WAS DAMAGED. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. DURING MANUFACTURER¿S INVESTIGATION OF THE RETURNED DEVICE IT WAS OBSERVED THAT APPROXIMATELY 80% OF THE CIRCUMFERENCE OF THE DISTAL END OF THE LOCKING/NEUTRAL GUIDE WAS DEFORMED/ BENT. THIS PRODUCT CONDITION WAS REEVALUATED AND DETERMINED TO BE REPORTABLE ON (B)(6) 2018. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7773405 ↗
• InjuryFeb 5, 2018Bent; Bent

  IT WAS REPORTED THAT DURING THE PLATING PORTION OF AN ORIF PROXIMAL TIBIA PROCEDURE ON (B)(6) 2018 THE SURGEON WAS HAVING TROUBLE CONNECTING NEUTRAL GUIDE TO THE AIMING ARM. AFTER ATTEMPTING SEVERAL COMMON TROUBLESHOOTING TECHNIQUES TO TRY SOLVING THE CONNECTING ISSUE, THE SCRUB TECH NOTICED THAT THE NEUTRAL GUIDES WERE BENT, CAUSING THEM NOT TO FUNCTION PROPERLY. THIS CONNECTING ISSUE BETWEEN THE DEVICES CAUSED AN ESTIMATED SURGICAL DELAY OF 10 MINUTES AND CAUSED THE SURGEON TO HAVE TO MAKE MORE INCISIONS THAN ORIGINALLY INTENDED. THESE ADDITIONAL INCISIONS WERE NEEDED TO LOCATE THE EXACT PLACEMENT OF THE SCREW HOLES, BECAUSE THE AIMING ARM WAS UNABLE TO BE USED. THE SIZES OF THE INCISIONS WERE LONGER IN LENGTH THAN THE ORIGINAL ONES CREATED. THE SURGERY WAS SUCCESSFULLY COMPLETED USING ONE OF THE DAMAGED GUIDES THAT APPEARED STILL FUNCTIONAL. THE PATIENT OUTCOME WAS REPORTED AS FINE FOLLOWING THE PROCEDURE. CONCOMITANT DEVICES REPORTED: PLATE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) LOCKING/NEUTRAL GUIDE FOR 3.5MM VA LCP PROXIMAL TIBIA AIMING ARM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7241341 ↗
• InjuryFeb 5, 2018Bent; Bent

  IT WAS REPORTED THAT DURING THE PLATING PORTION OF AN ORIF PROXIMAL TIBIA PROCEDURE ON (B)(6) 2018 THE SURGEON WAS HAVING TROUBLE CONNECTING NEUTRAL GUIDE TO THE AIMING ARM. AFTER ATTEMPTING SEVERAL COMMON TROUBLESHOOTING TECHNIQUES TO TRY SOLVING THE CONNECTING ISSUE, THE SCRUB TECH NOTICED THAT THE NEUTRAL GUIDES WERE BENT, CAUSING THEM NOT TO FUNCTION PROPERLY. THIS CONNECTING ISSUE BETWEEN THE DEVICES CAUSED AN ESTIMATED SURGICAL DELAY OF 10 MINUTES AND CAUSED THE SURGEON TO HAVE TO MAKE MORE INCISIONS THAN ORIGINALLY INTENDED. THESE ADDITIONAL INCISIONS WERE NEEDED TO LOCATE THE EXACT PLACEMENT OF THE SCREW HOLES, BECAUSE THE AIMING ARM WAS UNABLE TO BE USED. THE SIZES OF THE INCISIONS WERE LONGER IN LENGTH THAN THE ORIGINAL ONES CREATED. THE SURGERY WAS SUCCESSFULLY COMPLETED USING ONE OF THE DAMAGED GUIDES THAT APPEARED STILL FUNCTIONAL. THE PATIENT OUTCOME WAS REPORTED AS FINE FOLLOWING THE PROCEDURE. CONCOMITANT DEVICES REPORTED: PLATE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) LOCKING/NEUTRAL GUIDE FOR 3.5MM VA LCP PROXIMAL TIBIA AIMING ARM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7241334 ↗
• InjuryFeb 5, 2018Bent; Bent

  IT WAS REPORTED THAT DURING THE PLATING PORTION OF AN ORIF PROXIMAL TIBIA PROCEDURE ON (B)(6) 2018 THE SURGEON WAS HAVING TROUBLE CONNECTING NEUTRAL GUIDE TO THE AIMING ARM. AFTER ATTEMPTING SEVERAL COMMON TROUBLESHOOTING TECHNIQUES TO TRY SOLVING THE CONNECTING ISSUE, THE SCRUB TECH NOTICED THAT THE NEUTRAL GUIDES WERE BENT, CAUSING THEM NOT TO FUNCTION PROPERLY. THIS CONNECTING ISSUE BETWEEN THE DEVICES CAUSED AN ESTIMATED SURGICAL DELAY OF 10 MINUTES AND CAUSED THE SURGEON TO HAVE TO MAKE MORE INCISIONS THAN ORIGINALLY INTENDED. THESE ADDITIONAL INCISIONS WERE NEEDED TO LOCATE THE EXACT PLACEMENT OF THE SCREW HOLES, BECAUSE THE AIMING ARM WAS UNABLE TO BE USED. THE SIZES OF THE INCISIONS WERE LONGER IN LENGTH THAN THE ORIGINAL ONES CREATED. THE SURGERY WAS SUCCESSFULLY COMPLETED USING ONE OF THE DAMAGED GUIDES THAT APPEARED STILL FUNCTIONAL. THE PATIENT OUTCOME WAS REPORTED AS FINE FOLLOWING THE PROCEDURE. CONCOMITANT DEVICES REPORTED: PLATE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) LOCKING/NEUTRAL GUIDE FOR 3.5MM VA LCP PROXIMAL TIBIA AIMING ARM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7241280 ↗