NA 219393Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886705006229), received between Sep 8, 2020 and Jun 13, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Corroded” (4 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.

• MalfunctionJun 13, 2025Use of Device Problem; Device-Device Incompatibility; Material Deformation; Use of Device Problem; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE TIBIAL GUIDE ARM - TIP AIMER DEVICE WAS BENT OFF AND COULD NOT BE ALIGNED PROPERLY AND DID NOT FUNCTION PROPERLY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205928 ↗
• 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 ARM - TIP AIMER 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 12977682 ↗
• 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 ARM - TIP AIMER 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 12713164 ↗
• 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 ARM - TIP AIMER 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 12713116 ↗
• 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 ARM - TIP AIMER DEVICE WAS CORRODED. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11089207 ↗
• MalfunctionDec 29, 2020Degraded; Degraded

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING INSPECTION ON 12/15/2020, IT WAS OBSERVED THAT THE TIBIAL GUIDE ARM - TIP AIMER DEVICE WAS CORRODED. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11089204 ↗
• MalfunctionDec 14, 2020Degraded; Degraded

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE TIBIAL GUIDE ARM 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 11002694 ↗
• 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 10524652 ↗
• 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 10524576 ↗
• 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 10522247 ↗
• 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 10522191 ↗
• MalfunctionSep 8, 2020Degraded; Degraded

  THIS IS REPORT 1 OF 6 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 PATHMAKER TUNNEL NOTCHER *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 10503977 ↗