NA 213819Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705003303), received between Dec 9, 2019 and May 30, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 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.

• MalfunctionMay 30, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY A FIELD SERVICE ENGINEER IN AUSTRALIA THAT THE SAWTOOTH DRILL GUIDE DEVICE WAS DEFORMED/BENT. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17024829 ↗
• MalfunctionDec 5, 2020Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED BY THE SALES REP VIA EMAIL THAT DURING A SHOULDER SCOPE THE TEETH OF THE SAWTOOTH DRILL GUIDE ARE BROKEN AND BENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE WAS OLD AND IT WAS DISCARDED BY THE STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10951058 ↗
• MalfunctionMar 23, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A LABRAL SHOULDER REPAIR THE TEETH OF TWO SAWTOOTH DRILL GUIDES WERE BENT. 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 9867794 ↗
• MalfunctionMar 23, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A LABRAL SHOULDER REPAIR THE TEETH OF TWO SAWTOOTH DRILL GUIDES WERE BENT. 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 9867411 ↗
• MalfunctionDec 9, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING AN UNKNOWN PROCEDURE THE TIP OF TWO OF THE LUPINE STABILIZATION FISHMOUTH DRGDE EA WERE BENT. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9438906 ↗