NA 219390Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886705006199), received between Jan 17, 2019 and Mar 14, 2024 — classified as 12 malfunctions.

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

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP THAT DURING ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR PROCEDURE PERFORMED ON (B)(6) 2024 IT WAS OBSERVED THAT THE TIBIAL GUIDE BULLET DEVICE WAS STUCK. IT WAS REPORTED THAT ANOTHER TIBIAL GUIDE/BULLET WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OF SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18905839 ↗
• MalfunctionMar 22, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE TIBIAL GUIDE BULLET DEVICE WAS SLIGHTLY BENT. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. 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 16592934 ↗
• MalfunctionDec 23, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION THE TIBIAL GUIDE BULLET WELDED ITSELF. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. DURING AN IN HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE DEVICE WAS JAMMED/SEIZED. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13078276 ↗
• 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 BULLET 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 12713167 ↗
• 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 BULLET 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 12713098 ↗
• MalfunctionDec 14, 2020Degraded; Degraded

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE TIBIAL GUIDE BULLET 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

  MAUDE report 11002695 ↗
• 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 10524713 ↗
• MalfunctionSep 11, 2020Corroded; Corroded

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10523533 ↗
• 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 10522294 ↗
• 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 10211823 ↗
• MalfunctionJan 2, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE IT WAS FOUND THAT THE PRONGS AT THE TIP OF THEIR TIBIAL GUIDE BULLET ARE BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR DEVICE BUT STATED THAT THE DEVICE IS OLDER DEVICE. THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9539990 ↗
• MalfunctionJan 17, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TIP OF ONE OF THE SPIKES ON THEIR TIBIAL GUIDE BULLET BROKE OFF AND WERE UNABLE TO USE THE DEVICE. THE SALES REP STATED THAT NOTHING BROKE IN THE PATIENT AND THAT THE DEVICE BROKE OUTSIDE THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE DEVICE BUT STATED THAT THE DEVICE IS APPROXIMATELY SIX YEARS OLD AND HAS SEEN HEAVY USE IN THE FIELD. THE SALES REP STATED THAT THE DEVICE WAS DISCARDED. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8258416 ↗