REDAPT 71355344Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556580929), received between Dec 2, 2019 and Oct 5, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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.

• InjuryOct 5, 2020Defective Device; Material Twisted/Bent; Defective Device; Material Twisted/Bent

  IT WAS REPORTED THAT THE SURGEON REAMED FEMORAL CANAL WITH THE REDAPT 13X190 DISTAL REAMER. WHEN THE TIME CAME TO REMOVE, THE REAMER WOULD NOT STAY CONNECTED TO THE ADAPTOR. THERE WAS A DELAY OF ROUGHLY 45 MINUTES AS SURGEON TRIED TO RETRIEVE THE REAMER FROM THE PATIENT USING VICE GRIPS AND MALLET. ONCE REMOVED FROM THE PATIENT AND AFTER INSPECTION, THE PROXIMAL END OF THE REAMER WAS FOUND TO BE BENT. NO BACKUP S&N INSTRUMENT WAS AVAILABLE AND PROCEDURE WAS COMPLETED WITH THE SAME DEVICE FOLLOWING STANDARD OPERATION TECHNIQUE. NO PATIENT INJURY OCCURRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10632326 ↗
• MalfunctionDec 2, 2019Break; Break

  IT WAS REPORTED THAT DURING A THR PROCEDURE, WHILE REAMER WAS INSIDE THE PATIENT IT STRIPPED. NO DELAY. BACKUP DEVICE AVAILABLE. NO IMPACT OR INJURY TO PATIENT REPORTED.

  Patient problems: No Information

  MAUDE report 9398668 ↗