RESTORE 219342Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705005871), received between Nov 26, 2019 and Feb 16, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS IS REPORT 4 OF 15 FOR (B)(4). IT WAS REPORTED BY THE FIELD SERVICE ENGINEER THAT DURING INSPECTION, THE CUSTOMER OBSERVED THAT THE RESTORE FULLY FLUTED REAMER 12MM, 40-130MM (PLUS OR MINUS 5 PERCENT) DEVICE HAD CONTAMINATION INSIDE ITS CANNULATED SECTION. ACCORDING TO THE REPORT, THE EVENT OCCURRED BEFORE PROCESSING WHEN THE CUSTOMER DECIDED TO INSPECT THE DEVICE WITH THEIR BORESCOPE. IT WAS REPORTED THAT THE DEVICE WAS PURCHASED ON JUNE 2022; AND HAS NEVER BEEN USED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS SHELVED AND STORED IN CONTROLLED ENVIRONMENT IN THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16386074 ↗
• MalfunctionApr 1, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY SALES REP VIA PHONE THAT BEFORE AN ACL PROCEDURE THE PHYSICIAN NOTICED THAT THE SIZE OF THIS CRUCIATE + RETROREAMER BULLET WAS TOO BIG AND WOULDN´T FIT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. AFTER THE PROCEDURE WAS FINISHED THE REP INSPECTED HIS PRODUCTS AND NOTICED THAT THE FOLLOWING DEVICES WERE DULL: FULLY FLUTED REAMER (6 MM, 6.5 MM, 7 MM, 7.5 MM, 8 MM, 8.5 MM, 9 MM, 9.5 MM, 10 MM, 10.5 MM, 11 MM, 11.5 MM, 12 MM). ALL DEVICES ARE AVAILABLE TO BE RETURNED FOR EVALUATION. THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9913767 ↗
• MalfunctionNov 26, 2019Dull, Blunt; Dull, Blunt

  THIS IS REPORT 3 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TENDONHARV PIGTAIL PEELER EA DEVICE TORE THE GRAFT AND THE PROCEDURE HAD TO BE CANCELLED. IT WAS FURTHER REPORTED THAT THE RESTORE FULLFLUTE REAM 8 MM EA DEVICE WAS NOT ABLE TO CUT, AND ANOTHER RESTORE FULLFLUTE REAM 12 MM EA DEVICE WAS USED TO TRY TO MAKE THE TIBIAL TUNNEL; HOWEVER, IT WAS IN THE SAME CONDITION THAT IT WAS NOT ABLE TO CUT EITHER. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS 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 9375493 ↗