NA 04.005.538SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982086075), received between Apr 18, 2018 and Aug 3, 2020 — classified as 4 injuries.

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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2020Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  THE INITIAL COMPLAINT WAS REVIEWED AND FOUND NOT REPORTABLE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE SCREWS WERE NOT BROKEN AS PREVIOUSLY REPORTED. THERE IS NO ALLEGATION OF A MALFUNCTION AGAINST THE SCREWS.

  Patient problems: No Code Available; No Consequences Or Impact To Patient; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10359044 ↗
• InjuryAug 3, 2020Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  THE INITIAL COMPLAINT WAS REVIEWED AND FOUND NOT REPORTABLE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE SCREWS WERE NOT BROKEN AS PREVIOUSLY REPORTED. THERE IS NO ALLEGATION OF A MALFUNCTION AGAINST THE SCREWS.

  Patient problems: No Code Available; No Consequences Or Impact To Patient; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10358993 ↗
• InjuryJul 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED IN (B)(6) 2017, THE PATIENT UNDERWENT THE SURGERY BY USING A COMPETITORS FEMORAL IMPLANT SYSTEM IN ORDER TO PREVENT BONE FRACTURES DUE TO THE BREAST CANCER BEING SPREAD TO THE FEMUR. ON (B)(6) 2020, A REVISION SURGERY WAS PERFORMED TO REPLACE THE FEMORAL IMPLANTS DUE TO DEVICE BREAKAGE WITH SYNTHES TROCHANTERIC FIXATION NAIL ANTIROTATION (TFNA) LONG IMPLANTS. ON (B)(6) 2020, A REVISION SURGERY WAS PERFORMED DUE TO THE BREAKAGE OF THE TFNA LONG IMPLANTS. THE PATIENT WAS REVISED TO ANOTHER SET OF IMPLANTS. THERE WAS A ONE (1) HOUR SURGICAL DELAY DUE TO EXTENDED TIME IN REMOVING THE BROKEN DEVICE. IT WAS FURTHER REPORTED THE PATIENT ALSO HAD A NON-UNION WHICH MAY HAVE CONTRIBUTED TO THE DEVICE BREAKAGE. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: Impaired Healing; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10343611 ↗
• InjuryApr 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A PROXIMAL FEMUR FRACTURE USING A TROCHANTERIC FIXATION NAIL - ADVANCE (TFNA) ON (B)(6) 2017. POSTOPERATIVELY, A NON-UNION WAS IDENTIFIED ON A ROUTINE FOLLOW-UP X-RAY. PATIENT WAS ASYMPTOMATIC (NO COMPLAINTS OF PAIN OR DISCOMFORT). THE PATIENT DID NOT HEAL DUE TO LATERAL CORTEX PORTION OF THE FEMUR BONE WAS MISSING BECAUSE OF THE COMPLEX FRACTURE PATTERN. THE PATIENT UNDERWENT A REVISION ON (B)(6) 2018 AND RECEIVED A RIGHT TOTAL HIP REPLACEMENT. ALL THE REMOVED IMPLANTS WERE INTACT. THERE WERE NO ISSUES DURING THE REVISION AND NO SURGICAL TIME DELAY. THE PATIENT STATUS WAS STABLE. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7440858 ↗