NA 219957Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705007004), received between Sep 16, 2019 and Jan 15, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2020Crack; Material Twisted/Bent; Crack; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE THE CUSTOMER'S 23MM MODULAR DRIVE WAS BENT CAUSING THEIR 8 X 23MM MILAGRO ADVANCE INTERFERENCE SCREW TO CRACK. THE SCREW WAS REMOVED WITH NO FURTHER ISSUES. THE PROCEDURE WAS COMPLETED WITH OTHER DEVICES USING THE SAME BONE HOLE WITH NO PATIENT HARM BUT THERE WAS A TWO MINUTE SURGICAL DELAY TO THE CASE TO GRAB A NEW DRIVER AND SCREW. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. THE DEVICES WILL BE RETURNING FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 9590714 ↗
• MalfunctionSep 16, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP WHILE OBSERVING THE DEVICES THAT THE FOLLOWING: CORD CUTTER WAS NOT SLIDING PROPERLY AND MODULAR DRIVER 23MM WAS BENT AT THE DISTAL TIP THE SALES REP STATED THAT THE CUSTOMER DID NOT REPORT ANY PATIENT HARMS TO HIM. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. 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 9069726 ↗