TWISTR 232301Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705026173), received between Sep 3, 2019 and Sep 3, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Jam” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT THE FAILURE OF THE CRUCIATE+ BEATH PIN BULLET WAS IDENTIFIED DURING ITS CORRECT USE IN A CADAVEROUS COURSE, THE BEATH PIN 14'', WHICH WAS A PART OF THE DISPOSABLE KIT GOT TRAPPED AND LOCKED INSIDE THE BULLET. WHEN TRYING TO RELEASE IT, THE BULLET WAS BROKEN AND WAS REMAINING IN 2 PARTS IMAGES ATTACHED. BUT STILL THE DRILL DID NOT COME OUT. THE RECEIVED PHOTO WAS REVIEWED BY MANUFACTURER AND IT SHOWS A RESTORE ACL INSTRUMENTS 14" DRILL PT. PIN W/EYELET STUCK INSIDE THE BULLET COMPLAINT DEVICE. IT IS CLEAR IN THE PHOTO THAT THE DRILL PIN IS ABOUT HALF THE LENGTH IT IS SUPPOSED TO BE AND ALSO APPEARS BENT AT THE TIP. THE DRILL PIN IS PART OF THE FINISHED GOODS ACL DISPOSABLE KIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8958076 ↗