NA 219962Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886705007042), received between Jul 24, 2020 and Jun 25, 2024 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Degraded” (8 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 16, 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.

• MalfunctionJun 25, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING INSPECTION, IT WAS OBSERVED THAT THE GRAFT PREP SYS SLIDERUNIT DEVICE WAS MISSING A SCREW TO KEEP IT TOGETHER. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19606736 ↗
• MalfunctionAug 7, 2023Mechanical Jam; Mechanical Jam

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY SALES REP VIA EMAIL THAT DURING ANTERIOR CRUCIATE LIGAMENT REPAIR GRAFT PREP BOARD AND SLIDER UNIT DID NOT SLIDE ONTO THE TRACK WHILE IN USE TOGETHER. ACCORDING TO THE REPORT, BOTH SLIDER UNITS FROM BOTH ENDS WERE TRIED. IT WAS FURTHER REPORTED THAT THEY USED THE GRAFT GRASPERS IN THE STATIONARY HOLES ON THE BLUE FRAME OF THE BOARD 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 17471341 ↗
• MalfunctionAug 3, 2022Unintended Movement; Unintended Movement

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT TWO OF THE SLIDER UNIT DEVICES WERE NOT HOLDING. 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 15156760 ↗
• MalfunctionAug 3, 2022Unintended Movement; Unintended Movement

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT TWO OF THE SLIDER UNIT DEVICES WERE NOT HOLDING. 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 15156757 ↗
• 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 GRAFT PREP SYSTEM SLIDER UNIT DEVICE WAS CORRODED. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11089221 ↗
• 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 GRAFT PREP SYSTEM SLIDER UNIT DEVICE WAS CORRODED. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11089211 ↗
• MalfunctionSep 14, 2020Degraded; Degraded

  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 10527874 ↗
• MalfunctionSep 14, 2020Degraded; Degraded

  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 10527873 ↗
• MalfunctionSep 14, 2020Degraded; Degraded

  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 10527872 ↗
• MalfunctionSep 14, 2020Degraded; Degraded

  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 SLIDER UNIT (2 REQ) EA. ALL DEVICES ARE AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10527868 ↗
• MalfunctionSep 14, 2020Degraded; Degraded

  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 SLIDER UNIT (2 REQ) EA. ALL DEVICES ARE AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10527866 ↗
• 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 10523626 ↗
• 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 10523379 ↗
• 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 10523369 ↗
• 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 10522692 ↗
• 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 10522480 ↗
• MalfunctionJul 24, 2020Corroded; Degraded; Corroded; Degraded

  THIS IS REPORT 2 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 10319585 ↗