NA 356.825Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982195616), received between Apr 2, 2019 and Aug 18, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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.

• MalfunctionAug 18, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE AN OPEN REDUCTION/INTERNAL FIXATION SURGERY FOR A FEMORAL TROCHANTERIC FRACTURE WITH PFNA IMPLANTS ON AN UNKNOWN DATE. ON (B)(6) 2023, THE PATIENT UNDERWENT REMOVAL SURGERY BECAUSE PROXIMAL BONE UNION HAD BEEN ACHIEVED; HOWEVER, FOR UNKNOWN REASONS, THE PFNA NAIL HAD TO BE REMOVED IN ORDER TO INSERT A RETROGRADE NAIL INTO THE DISTAL FEMORAL FRACTURE. WHEN REMOVING THE PFNA, THE SURGEON ATTACHED AN EXTRACTION SCREW TO THE BLADE AND TURNED IT IN THE ¿ATTACH¿ DIRECTION, BUT THE TURNING LOCK OF THE BLADE WAS NOT RELEASED. AS THE SURGEON CONTINUED TO TURN THE EXTRACTION SCREW, ONLY THE PART AT THE BLADE END CAME OFF. AFTER THAT, THE SURGEON INSERTED A 3.0 K-WIRE INTO THE BLADE AND REATTACHED THE DISLODGED PART TO THE BLADE END AT THE END OF A HOLLOW SCREWDRIVER FOR THE BLADE. THE SURGEON CONFIRMED THAT THE BLADE HAD RETURNED TO ITS ORIGINAL SATE. THEN THE EXTRACTION SCREW WAS TURNED IN THE ¿ATTACH¿ DIRECTION TO ATTACH THE BLADE. ALTHOUGH THE ATTACHMENT WAS BAD, THE BLADE AND EXTRACTION SCREW COULD BE CONNECTED, SO THE BLADE WAS PULLED OUT WITHOUT RELEASING THE LOCK. THE SURGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17573602 ↗
• InjuryJun 27, 2019Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, AN OPEN REDUCTION INTERNAL FIXATION (ORIF) WITH JAPANESE PROXIMAL FEMORAL NAIL ANTI-ROTATION (PFNA) - II SYSTEM WAS APPLIED TO SURGERY FOR FEMORAL TROCHANTERIC FRACTURE. DURING INSERTION OF A PFNA-II BLADE, IT PENETRATED THE FEMORAL HEAD. THE SURGEON COMMENTED THAT DURING THE MEASUREMENT FOR THE BLADE SELECTION, THE END OF THE PROTECTION SLEEVE WAS NOT IN CONTACT WITH THE BONE. DUE TO THIS, THE MEASUREMENT VALUE BECAME LONGER THAN THE CORRECT ONE. THUS, THE LENGTH OF THE SELECTED BLADE WAS LONGER THAN THE PROPER LENGTH. ALSO, DURING THE PROCESS OF HAMMERING, IMAGES WERE NOT TAKEN CONTINUOUSLY, THUS, THE SURGEON DID NOT CHECK THE IMAGES PROPERLY. DURING THE SAME PROCEDURE, THE SURGEON TRIED TO REMOVE THE BLADE. TO DO THIS, THE SURGEON CONNECTED AN EXTRACTION SCREW WITH THE BLADE YET, AN EXTRACTION SCREW COULD NOT CONNECTED PROPERLY DUE TO AN UNKNOWN REASON. AS A RESULT, THE CONNECTION PORTION BETWEEN AN EXTRACTION SCREW AND THE BLADE BROKE WHILE HAMMERING. THUS, THE BLADE COULD NOT BE REMOVED WITH AN UNKNOWN REMOVAL DEVICE. THEN, THE BLADE WAS REMOVED USING ANOTHER UNKNOWN REMOVAL

  Patient problems: Blood Loss; Bone Fracture(s); Injury; No Code Available

  MAUDE report 8741476 ↗
• MalfunctionApr 2, 2019Mechanical Problem; Device-Device Incompatibility; Mechanical Problem; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN EXTRACTION SCREW FOR PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) BLADE WAS DEFECTIVE. IT WAS UNKNOWN WHERE THE ISSUE OCCURRED. SURGICAL PROCEDURE AND PATIENT INVOLVEMENT WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN PFNA BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) EXTRACTION SCREW FOR PFNA BLADE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8474506 ↗