RESTORE 219313Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705005680), received between Nov 22, 2019 and Aug 2, 2022 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE TIP ON THE RESTORE FEMORAL AWL 45° DEVICE WAS BROKEN. 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 15149126 ↗
• MalfunctionFeb 6, 2020Dull, Blunt; Material Twisted/Bent; Dull, Blunt; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE THESE RESTORE FEMORAL AWL DEVICES WERE DULL AND SLIGHTLY BENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THESE DEVICES WILL RETURN FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9678429 ↗
• MalfunctionFeb 6, 2020Dull, Blunt; Material Twisted/Bent; Dull, Blunt; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE THESE RESTORE FEMORAL AWL DEVICES WERE DULL AND SLIGHTLY BENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THESE DEVICES WILL RETURN FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9678379 ↗
• MalfunctionDec 18, 2019Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) PROCEDURE, IT WAS OBSERVED THAT THE TIP OF THE RESTORE FEMORAL AWL DEVICE WAS EXTREMELY DULL. 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 9490562 ↗
• MalfunctionNov 22, 2019Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT) RECONSTRUCTION SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TIP OF THE CUSTOMER'S RESTORE FEMORAL AWL 45 DEGREE WAS DULL. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO PATIENT HARM BUT THERE WAS A THREE MINUTE SURGICAL DELAY TO THE CASE TO GRAB ANOTHER AWL. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE DEVICE BUT STATED THAT THE DEVICE WAS AN OLDER DEVICE AND HAD SEEN HEAVY USED IN THE FIELD. THERE WAS A 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: Not Applicable

  MAUDE report 9362517 ↗