RESTORE 219346Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705005895), received between Apr 1, 2020 and Sep 15, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionSep 15, 2024Inaccurate Information; Inaccurate Information

  THIS IS REPORT 5 OF 5 FOR (B)(4). IT WAS REPORTED FROM CHINA THAT THE LOT NUMBER ON THE LABEL ON THE RESTORE FULLFLUTE REAM 6MM DEVICE WAS NOT CONSISTENT WITH THE LOT NUMBER THAT WAS ETCHED ON IT. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. 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 20220929 ↗
• MalfunctionApr 11, 2023Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN GERMANY THAT DURING AN UNKNOWN ARTHROSCOPY PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE FULLY FLUTED REAMER DEVICE SUDDENLY AND UNEXPECTEDLY BROKE INTO SEVERAL PIECES AT THE TIP. ACCORDING TO THE REPORT, THE FRAGMENTS FROM THE DRILL COULD ALL BE RECOVERED FROM THE PATIENT'S KNEE. 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 16716675 ↗
• MalfunctionFeb 16, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS IS REPORT 10 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 6MM, 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16386088 ↗
• MalfunctionApr 1, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY SALES REPRESENTATIVE VIA CONVENTIONS AND MEETINGS THAT BEFORE AN ANT.CRUCIATE LIGAMENT DECOMPRESSION PROCEDURE THE PHYSICIAN NOTICED THAT THE SIZE OF THE 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 9910522 ↗