NA 219391Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886705006205), received between Nov 5, 2018 and Mar 30, 2023 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Corroded” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED BY SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE TIBIAL GUIDE RAIL DEVICE WAS SLIGHTLY BENT AND WOULD NOT INSERT INTO EITHER AIMING GUIDE ARM. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16648378 ↗
• MalfunctionOct 12, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED BY SALES REP THAT DURING A KNEE ANTERIOR CRUCIATE LIGAMENT ARTHROSCOPY PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT WHILE USING A TIBIAL GUIDE ARM - ELBOW AIMER, THE DRILL PIN CONTINUED TO MISS THE POINT. ACCORDING TO THE REPORT, THE BULLET HAD A DIFFICULT TIME STABILIZING AND THE RAIL ALSO SEEMED LOOSE FROM THE BULLET. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15589252 ↗
• MalfunctionAug 26, 2022Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE KNOB THAT HELD THE TIBIAL GUIDE RAIL WAS NOT HOLDING ANYMORE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE TIBIAL RATCHET PAWL AND THE TIBIAL RATCHET SPRING ON THE DEVICE WERE MISSING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15302890 ↗
• MalfunctionDec 10, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE TIBIAL GUIDE RAIL DEVICE WAS BENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12977620 ↗
• MalfunctionOct 28, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING THE ROUTINE PROCESSING AND STERILIZATION FROM WEAR AND TEAR, IT WAS OBSERVED THAT THE TIBIAL GUIDE RAIL DEVICE WAS BROKEN. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12713185 ↗
• MalfunctionOct 28, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING THE ROUTINE PROCESSING AND STERILIZATION FROM WEAR AND TEAR, IT WAS OBSERVED THAT THE TIBIAL GUIDE RAIL DEVICE WAS BROKEN. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12713128 ↗
• MalfunctionDec 29, 2020Degraded; Degraded

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING INSPECTION ON (B)(6) 2020, IT WAS OBSERVED THAT THE TIBIAL GUIDE RAIL DEVICE WAS CORRODED. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11089222 ↗
• MalfunctionDec 29, 2020Degraded; Degraded

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING INSPECTION ON (B)(6) 2020, IT WAS OBSERVED THAT THE TIBIAL GUIDE RAIL DEVICE WAS CORRODED. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11089214 ↗
• MalfunctionNov 17, 2020Degraded; Degraded

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE TIBIAL GUIDE RAIL DEVICE WAS RUSTY. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION ,OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10853794 ↗
• MalfunctionSep 11, 2020Corroded; Corroded

  IT WAS REPORTED BY THE AFFILIATE VIA CST THAT DURING INSPECTION OF THE ORTHOKIT THE FOLLOWING DEVICES WERE RUSTED: TIBIAL GUIDE RAIL, TIBIAL GUIDE ARM-TIP AIMER, TIBIAL GUIDE BULLET, CRUCIATE + FEMORAL CAPTURE, GRAFT PREP SYS SLIDERUNIT (2 REQ) *EA. ALL DEVICES ARE AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10524322 ↗
• MalfunctionSep 11, 2020Corroded; Corroded

  IT WAS REPORTED BY THE AFFILIATE VIA CST THAT DURING INSPECTION OF THE ORTHOKIT THE FOLLOWING DEVICES WERE RUSTED: TIBIAL GUIDE RAIL, TIBIAL GUIDE ARM-TIP AIMER, TIBIAL GUIDE BULLET, CRUCIATE + FEMORAL CAPTURE, GRAFT PREP SYS SLIDERUNIT (2 REQ) *EA. ALL DEVICES ARE AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10524049 ↗
• MalfunctionSep 11, 2020Corroded; Corroded

  IT WAS REPORTED BY THE AFFILIATE VIA CST THAT DURING INSPECTION OF THE ORTHOKIT THE FOLLOWING DEVICES WERE RUSTED: TIBIAL GUIDE RAIL, TIBIAL GUIDE ARM-TIP AIMER, TIBIAL GUIDE BULLET, CRUCIATE + FEMORAL CAPTURE, GRAFT PREP SYS SLIDERUNIT (2 REQ) *EA. ALL DEVICES ARE AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10523547 ↗
• MalfunctionSep 11, 2020Corroded; Corroded

  IT WAS REPORTED BY THE AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT WHILE INSPECTING THE ORTHOKIT, IT WAS FOUND THAT THE ARTICLES IN THE LENDING SET WERE RUSTING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10522152 ↗
• MalfunctionSep 11, 2020Corroded; Corroded

  IT WAS REPORTED BY THE AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT WHILE INSPECTING THE ORTHOKIT, IT WAS FOUND THAT THE ARTICLES IN THE LENDING SET WERE RUSTING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10521835 ↗
• MalfunctionJul 24, 2020Corroded; Degraded; Corroded; Degraded

  THIS IS REPORT 5 OF 5 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING STERILIZATION PRIOR TO AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE GRAFT PREP SYS SLIDERUNIT (2 REQ) EA DEVICE HAD SOME RUST SPOTS PARTICULARLY ON THE WRITINGS (LETTERS). IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10319594 ↗
• MalfunctionJun 30, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIAGEMENT (ACL) PROCEDURE, IT WAS OBSERVED THAT THE RESTORE TIBIAL GUIDE/RATCHET, ±10%, THE TIBIAL GUIDE BULLET AND THE TIBIAL GUIDE RAIL WERE ALL BENT. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICES. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10211821 ↗
• MalfunctionNov 5, 2018Failure to Align; Failure to Align

  ADDITIONAL EVENT INFORMATION RECEIVED ON 11/19/2018. IT WAS REPORTED BY AN AFFILIATE THAT TRACKING# RECEIVED VIA EMAIL IS (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8038799 ↗