RESTORE 219301Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886705005567), received between Jul 11, 2018 and Aug 22, 2023 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED BY SALES REP VIA EMAIL THAT DURING ACL (ANTERIOR CRUCIATE LIGAMENT) RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE RESTORE TIBIAL GUIDE/RATCHET, ±10% DEVICE WAS MALFUNCTIONING AS IT WAS NOT HITTING ITS AIM POINT. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE SHOWED NOTICEABLE MARKS OF WEAR WHICH INDICATES THAT THE DEVICE WAS HEAVILY USED. ALSO, IT WAS IDENTIFIED STAINS AND DISCOLORATION MARKS. THE THREE PARTS (FRAME, CANNULA AND THE SLIDER) WERE DISASSEMBLED, THEY COULD BE CORRECTLY REASSEMBLED, ALSO SCRATCHES IN THE SURFACE OF THE CANNULA WERE IDENTIFIED, THE NUMBERS MARKS WERE FADED. THE DISTAL PART OF THE BULLET HAD SOME PARTS DEFORMED. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED WITH A FIVE MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17598494 ↗
• MalfunctionMay 23, 2023Device-Device Incompatibility; Material Deformation; Mechanical Jam; Device-Device Incompatibility; Material Deformation; Mechanical Jam

  THIS IS REPORT 1 OF 3 FOR PC-(B)(4). IT WAS REPORTED BY THE AFFILIATE IN BELGIUM THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT PINS ON TWO RESTORE TIBIAL GUIDE/RATCHET, ±10% DEVICES GOT STUCK AND WERE TWISTED, 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 16985647 ↗
• MalfunctionMay 23, 2023Device-Device Incompatibility; Material Deformation; Mechanical Jam; Device-Device Incompatibility; Material Deformation; Mechanical Jam

  THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN BELGIUM THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT PINS ON TWO RESTORE TIBIAL GUIDE/RATCHET, ±10% DEVICES GOT STUCK AND WERE TWISTED, 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 16985645 ↗
• MalfunctionJan 4, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE RESTORE TIBIAL GUIDE/RATCHET DEVICE WAS BROKEN. 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 16098557 ↗
• MalfunctionDec 22, 2022Mechanical Jam; Mechanical Jam

  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 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 16036082 ↗
• MalfunctionDec 14, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY ON (B)(6)2022 , IT WAS OBSERVED THAT THE PINS ON THE RESTORE TIBIAL GUIDE/RATCHET, ±10% DEVICE WERE IN FRONT OF THE TWO PRONGS AND NOT IN BETWEEN. 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 15978953 ↗
• MalfunctionMay 10, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT AUTOGRAFT PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE MOVEABLE SCREW ON THE RESTORE TIB GDE/RACHET, ±10% DEVICE WAS NOT MOVING. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11801021 ↗
• MalfunctionNov 24, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE RESTORE TIBIAL GUIDE/RATCHET, ±10% BROKE. ALL FRAGMENTS GENERATED WERE RETRIEVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10896149 ↗
• 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 10211829 ↗
• MalfunctionAug 15, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ACL REPAIR THAT THE SPRING MECHANISM IN CUSTOMER'S TIBIAL RATCHET GUIDE WAS BROKEN AND WOULD NOT STAY TOGETHER. THE SURGEON COMPLETED THE PROCEDURE BY HAVING ONE PERSON HOLDING THE DEVICE TOGETHER WHILE HE WAS DRILLING. THE SALES REP CONFIRMED THAT THERE WERE NO PATIENT CONSEQUENCES OR DELAY. THE SALES REP COULD NOT PROVIDE A LOT NUMBER OR AGE OF THE DEVICE BUT STATED THE DEVICE WAS VERY WORN AND HAS SEEN HEAVY USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7784957 ↗
• MalfunctionJul 11, 2018Break; Break

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING PRE-SURGERY INSPECTION AT THE WAREHOUSE, IT WAS OBSERVED THAT THE DRILL POINT PIN DEVICE WAS BROKEN INSIDE THE RATCHET GUIDE DEVICE. 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 7677458 ↗