NA 357.383Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982196118), received between Jan 17, 2017 and Oct 1, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, A 3.2 TROCAR WAS FOUND BROKEN IN THE STERILE PROCESSING DEPARTMENT AFTER BEING WASHED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.2MM TROCAR 232MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10613299 ↗
• MalfunctionNov 13, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING ROUTINE INCOMING INSPECTION A LOANER SET AT FSL UPS MALDEN, MA SITE, IT WAS OBSERVED THAT A TROCAR WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9316475 ↗
• MalfunctionJan 17, 2017Bent; Bent

  IT WAS REPORTED THAT AN INITIAL TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE FOR THE LEFT FEMUR TOOK PLACE ON (B)(6) 2016 WHERE SEVERAL DEVICE MALFUNCTIONS OCCURRED. THE HELICAL BLADE COUPLING SCREW BROKE INTO TWO PIECES WHILE BEING HAMMERED BY AN UNKNOWN MALLET. THOSE PIECES WERE RETRIEVED WITH DIFFICULTY AND UNSPECIFIED ADDITIONAL INTERVENTION RESULTING IN A THIRTY (30) MINUTE SURGICAL DELAY. ADDITIONALLY, AS THE HELICAL BLADE INSERTER WAS REMOVED IT WAS NOTED THE TIP WAS BROKEN IN PIECES AS A RESULT FROM THE HAMMERING. ALL PIECES WERE RETRIEVED FROM THE BROKEN INSERTER. IT WAS ALSO DETERMINED THE THREADS OF THE BLADE GUIDE SLEEVE BECAME DAMAGED WHILE THE SURGEON WAS TRYING TO REMOVE THE HELICAL BLADE INSERTER. THE BUTTRESS COMPRESSION NUT FOR THE BLADE GUIDE SLEEVE COULD NO LONGER BE TURNED, AND WAS NO LONGER USABLE BECAUSE OF THE DAMAGE TO THE THREADS. THIS PUSHED THE BLADE GUIDE SLEEVE INTO THE 130 DEGREE AIMING ARM. THE BUTTRESS COMPRESSION NUT AND THE BLADE GUIDE SLEEVE BECAME STUCK TOGETHER. DURING THE IMPLANTATION OF THE HELICAL BLADE AND THE NAIL THE SURGEON REPORTED DIFFICULTY IN IMPLANTING THE TWO DEVICES. A PAIR OF NON-SYNTHES PLIERS WAS USED TO REMOVE THE HELICAL BLADE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6255815 ↗