NA 357.386Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982196132), received between Aug 31, 2017 and Nov 18, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• MalfunctionNov 18, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019 WHILE USING A TROCHANTERIC FIXATION NAIL (TFN) NAIL THE SURGEON MISSED THE NAIL WHEN DRILLING AND IT RESULTED IN THE SCREW MISSING THE NAIL. THE SURGEON TRIED TO REDO IT BUT DECIDED TO LEAVE IT OUTSIDE THE NAIL. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) 11.0MM/8.0MM PROTECTION SLEEVE 153MM. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9336333 ↗
• MalfunctionAug 31, 2017Sticking; Sticking

  IT WAS REPORTED THAT ONE (1) PROTECTION SLEEVE, ONE (1) DRILL SLEEVE AND ONE (1) TROCAR SEEM TO BE BENT AND HAVE STARTED STICKING TOGETHER DUE TO WEAR AND TEAR OVER TIME, THUS NEEDING REPAIR. THERE IS NO PATIENT INVOLVEMENT. THIS COMPLAINT IS FOR ONE DEVICES. (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6836638 ↗