NA 219392Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705006212), received between Nov 5, 2018 and Jan 6, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2023Mechanical Jam; Mechanical Jam

  THIS IS REPORT 2 OF 2 FOR (B)(4). 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 RESTORE TIBIAL GUIDE/RATCHET, ±10% DEVICE AND THE TIBIAL GUIDE ARM - ELBOW AIMER DEVICE BECAME STUCK WHEN THE SURGEON WAS USING WIRE DRIVER TO INSERT PASSING PIN THROUGH THE DEVICE. ACCORDING TO THE REPORT, THE PASSING PIN WOULD NOT ADVANCE AND WAS STUCK IN THE REAMER BULLET. IT WAS REPORTED THAT THE SURGEON REMOVED THE DEVICE AND WAS UNABLE TO REMOVE THE PIN. IT WAS REPORTED THAT THE SURGEON HAD TO FREEHAND DRILLED THE PASSING PIN TO COMPLETE THE PROCEDURE AS THERE WAS NO OTHER TIBIAL AIMER AVAILABLE. 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 16117419 ↗
• 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 - ELBOW 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 12713168 ↗
• 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 - ELBOW 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 12713096 ↗
• MalfunctionNov 5, 2018Failure to Align; Failure to Align

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TIBIAL GUIDE ARM - ELBOW AIMER WAS NOT LINING UP WITH THE TIBIAL GUIDE RAIL. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP WAS NOT PRESENT DURING THE CASE AND COULD NOT PROVIDE ANY MORE DETAILS. 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 8038798 ↗