RESTORE 219348Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886705005918), received between Jul 12, 2019 and Sep 15, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2024Inaccurate Information; Inaccurate Information

  THIS IS REPORT 8 OF 10 FOR (B)(4). IT WAS REPORTED FROM CHINA THAT THE LOT NUMBER ON THE LABEL ON THE RESTORE FULLFLUTE REAM 8MM 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 20220914 ↗
• MalfunctionFeb 16, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS IS REPORT 14 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 8MM, 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 16386095 ↗
• MalfunctionMay 27, 2021Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP THAT THE RESTORE FULLFLUTE REAM 8MM DEVICE WAS DULL. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11895946 ↗
• MalfunctionMay 27, 2021Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP THAT THE RESTORE FULLFLUTE REAM 8MM DEVICE WAS DULL. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11895914 ↗
• 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 9911557 ↗
• MalfunctionMar 17, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE TWO OF THE FULLY FLUTED REAMER WERE FOUND NOT SHARP ANYMORE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICES WERE DISCARDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9843508 ↗
• MalfunctionMar 17, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE TWO OF THE FULLY FLUTED REAMER WERE FOUND NOT SHARP ANYMORE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICES WERE DISCARDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9843419 ↗
• MalfunctionNov 26, 2019Dull, Blunt; Dull, Blunt

  THIS IS REPORT 2 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA 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 8MM *EA DEVICE WAS NOT ABLE TO CUT, AND ANOTHER RESTORE FULLFLUTE REAM 8MM 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 9375491 ↗
• MalfunctionJul 12, 2019Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE WITH THE CUSTOMER'S RESTORE FULL FLUTE REAMER 7 MM AND RESTORE FULL FLUTE REAMER 8 MM. THEY HAD THE TIBIAL GUIDE PIN IN PLACE AND IT WAS TIME TO REAM THE TIBIA TO CREATE OUR 8 MM TUNNEL. THE DOCTOR HAD THE 8 MM FLUTED REAMER CHUCKED UP AND SLID OVER THE GUIDE WIRE TO ENGAGE THE TIBIA. HE BEGAN DRILLING AND ENGAGED THE TIBIAL CORTEX WITH THE REAMER. THE REAMER WAS SPINNING ON THE TIBIAL CORTEX AND THE DOCTOR WAS PUSHING HARDER THAN HE NORMALLY HAS TO PUSH TO BREAK THE NEAR CORTEX. THE REAMER CONTINUED TO SPIN WITHOUT MAKING ADVANCEMENT AND NOW BEGAN SMOKING. AT THIS POINT HE STOPPED WHAT HE WAS TRYING TO DO AND ASKED FOR A SMALLER FLUTED REAMER, THINKING THAT MAYBE THE 8 MM FLUTED WAS DULL (WE USE THESE REAMERS FOR EVERY ACL). THE SURGICAL TECH LOADED A 7 MM FLUTED REAMER AND THEY REPEATED THE EXACT SAME STEPS AND EXPERIENCED THE SAME RESULTS. THE REAMER SPINNING ON THE CORTEX, NOT MAKING ADVANCEMENT, AND SMOKING HEAVILY. ONCE HE CAME OFF WITH THIS REAMER WE NOTICED QUITE A FEW METAL SHAVINGS AND THE AREA AROUND THE GUIDE PIN WHERE THE REAMER WAS SPINNING WAS COLORED BLACK (GUESSING FROM WHERE THE REAMER WAS SPI

  Patient problems: Not Applicable

  MAUDE report 8785867 ↗