RESTORE 219358Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705005987), received between Dec 7, 2018 and Jul 3, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionJul 3, 2023Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED BY SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE ON (B)(6)2023, IT WAS OBSERVED THAT THE RESTORE FEMORAL AIMER 8MM OFFSET PIN GOT STUCK WHILE PASSING GUIDE. ACCORDING TO THE REPORT, THE PHYSICIAN WAS NOT ABLE TO GET THE NEEDLE OUT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A MINIMUM SURGICAL DELAY 2-3 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17247304 ↗
• MalfunctionDec 7, 2018Fracture; Fracture

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHEN DRILLING THE DISPOSABLE ACL BAYPINS W/EYE .094X18", ONE OF THE PINS BROKE OFF IN THEIR FEMORAL AIMER 8MM OFFSET IN THE PATIENT. THE SALES REP STATED THAT THEY ARE UNABLE TO REMOVE THE BROKEN PIN FROM THE DEVICE. THE SALES REP STATED THAT THERE WAS NO DEBRIS LEFT IN THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE BY DOWNSIZING TO A DIFFERENT SIZE AND DRILL. THE SALES REP REPORTED THAT THERE WERE NO PATIENT CONSEQUENCES BUT THERE WAS A FIVE MINUTE DELAY IN THE CASE. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE DEVICE BUT STATED THAT THE DEVICE IS AN OLDER DEVICE. THE DEVICE WILL BE RETURNING FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8142492 ↗
• MalfunctionDec 7, 2018Fracture; Fracture

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHEN DRILLING THE DISPOSABLE ACL BAYPINS W/EYE .094X18", ONE OF THE PINS BROKE OFF IN THEIR FEMORAL AIMER 8MM OFFSET IN THE PATIENT. THE SALES REP STATED THAT THEY ARE UNABLE TO REMOVE THE BROKEN PIN FROM THE DEVICE. THE SALES REP STATED THAT THERE WAS NO DEBRIS LEFT IN THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE BY DOWNSIZING TO A DIFFERENT SIZE AND DRILL. THE SALES REP REPORTED THAT THERE WERE NO PATIENT CONSEQUENCES BUT THERE WAS A FIVE MINUTE DELAY IN THE CASE. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE DEVICE BUT STATED THAT THE DEVICE IS AN OLDER DEVICE. THE DEVICE WILL BE RETURNING FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8142038 ↗