NA 03.010.411Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10886982280220), received between Jun 29, 2017 and Sep 14, 2026 — classified as 7 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Break” (42 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Break

  It was reported that when the PFNA blade is knocked out, the thread of the extraction instrument has broken off. There was no patient harm or surgical delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50755710 ↗
• MalfunctionFeb 20, 2026Device-Device Incompatibility

  DURING THE ABLATION OF THE NAIL, THE NAIL WAS STUCK ON THE PFNA BLADE EXTRACTION SCREW. IT WAS IMPOSSIBLE TO DETACH THE NAIL FROM THE INSTRUMENT. (LOAN KIT.)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402718 ↗
• MalfunctionJan 5, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE ITEM WAS WEDGED ONTO THE END OF THE HANDLE. THE PRODUCT DAMAGE WAS IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23967188 ↗
• MalfunctionDec 4, 2025Break; Break

  DURING THE PFNA BLADE REMOVAL THE TIP OF THE THREADED PORTION OF EXTRACTION SCREW FOR PFNA BLADE SNAPPED INSIDE THE BLADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23719693 ↗
• MalfunctionAug 4, 2025Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT REMOVAL SURGERY FOR THE PFNA. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2023. IN THE SURGERY, THE SURGEON ATTEMPTED TO CONNECT THE EXTRACTION SCREW TO THE BLADE CLOCKWISE INSTEAD OF COUNTERCLOCKWISE AND WAS UNABLE TO ATTACH IT. WHEN THE SURGEON ATTEMPTED TO FORCE THE CONNECTION BY HAMMERING, THE THREADED PART AT THE TIP OF THE EXTRACTION SCREW BROKE AND THE HEXAGONAL PART BROKE OFF. THE SURGEON THEN ATTEMPTED TO UNLOCK THE BLADE ROTATION LOCKING MECHANISM BUT WAS UNABLE TO DO SO BECAUSE THERE WAS NO SCREWDRIVER THAT MATCHED THE BLADE'S HEXAGONAL DIMENSIONS. THE SURGEON SHAVED THE OUTER CORTEX AROUND THE BLADE AND ATTEMPTED TO REMOVE IT BY GRASPING IT WITH PLIERS, BUT IT WOULD NOT MOVE AT ALL. DUE TO THE RISK OF CAUSING AN IATROGENIC FRACTURE, HE GAVE UP ON REMOVING IT AND ENDED THE SURGERY. THERE WERE NO FRAGMENTS INSIDE THE BODY. THE SURGERY WAS COMPLETED WITH A MORE THAN SIXTY (60) MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22702172 ↗
• MalfunctionMar 4, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024.THE PFNA EXTRACTION SCREW BROKE DURING THE PROCEDURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21517823 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2024, THE EXTRACTION SCREWDRIVER BROKE INTO TWO PIECES. A NEW TRAY WAS OPENED. THERE WAS NO PATIENT CONSEQUENCE. PROCEDURE WAS COMPLETED WITH A FIFTEEN MINUTE DELAY. THIS REPORT IS FOR AN EXTRACTION SCREW FOR PFNA BLADE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20040476 ↗
• MalfunctionJul 5, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN IT WAS IDENTIFIED THAT PFNA BLADE PERF L110 TAN IS ATTACHED TO THE T-HANDLE AND ARE UNABLE TO UNTHREAD THE PART. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS REPORT IS FOR ONE (1) EXTRACTION SCREW FOR PFNA BLADE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19684621 ↗
• MalfunctionMar 27, 2024Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS DISCOVERED THAT THE EXPLANTATION SCREWDRIVER, FOR THE BLADE, WAS DEFECTIVE AND DID NOT WORK. THIS REPORT INVOLVES ONE (1) EXTRACTION SCREW FOR PFNA BLADE. THIS IS REPORT 1 OF 1 FOR (B)(4) .

  Patient problems: Insufficient Information

  MAUDE report 18985987 ↗
• InjuryOct 5, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SPAIN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THERE HAS BEEN A PROBLEM WHEN REMOVING A PFNA NAIL, SPECIFICALLY IT HAS NOT BEEN POSSIBLE TO REMOVE THE BLADE BECAUSE THE EXTRACTOR FOR THE BLADE COULD NOT BE CONNECTED. WHEN TRYING TO CONNECT IT, IT DID NOT SCREW, AS IF IT HAD BEEN STRIPPED, WHICH MADE IT IMPOSSIBLE TO CONNECT THE EXTRACTOR. AFTER TRYING IN OTHER WAYS, THEY COULD NOT GET THE NAIL OUT. THE NAIL AND THE BLADE REMAINED INSIDE. THERE WAS A SURGICAL DELAY OF THREE (3) HOURS. THIS REPORT INVOLVES ONE (1) EXTRACTION SCREW FOR PFNA BLADE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17878405 ↗
• MalfunctionSep 8, 2023Device-Device Incompatibility; Device-Device Incompatibility

  PATIENT STATUS/ OUTCOME: NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17711737 ↗
• MalfunctionJun 30, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT DURING AN INSPECTION IN THE ORTHOKIT LOANER DEPARTMENT AT LOCAL OPERATING COMPANY (LOC), IT WAS FOUND THAT THE THREAD OF THE EXTRACTION SCREW FOR PFNA BLADE IS BROKEN OFF. THE PRODUCT WAS NOT COMPLAINED BY ANY CUSTOMER. THERE WAS NO PATIENT OR SURGERY IMPACT. THIS REPORT IS FOR ONE (1) EXTRACTION SCREW FOR PFNA BLADE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243608 ↗
• MalfunctionMay 25, 2023Contamination /Decontamination Problem; Device-Device Incompatibility; Contamination /Decontamination Problem; Device-Device Incompatibility

  THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17007094 ↗
• MalfunctionMay 25, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED, THAT DURING A PROCEDURE ON (B)(6) 2023. THE PFNA BLADE WOULD NOT LOCK. THE EXTRACTION SCREW WAS USED TO REMOVE THE BLADE, BUT THEN WOULD NOT RELEASE FROM THE EXTRACTION SCREW. A SECOND SET OF THE SAME INSTRUMENTS WERE USED TO COMPLETE THE PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXTRACTION SCREW FOR PFNA BLADE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17004412 ↗
• MalfunctionMay 23, 2023Break; Break

  DEVICE REPORT FROM NEW ZEALAND REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, AN EXTRACTION SCREW WAS BROKEN. THIS REPORT IS FOR AN EXTRACTSCR F/PFNA BLADE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16984323 ↗
• MalfunctionMay 2, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO FEMORAL HEAD NECROSIS. IN THE SURGERY, THE BLADE AND EXTRACTION INSTRUMENT BECAME STUCK TOGETHER AND COULD NOT BE REMOVED AFTER THE BLADE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE EXTRACTION SCREW FOR PFNA BLADE. THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS THE ADVERSE EVENT CAUSING THE REMOVAL SURGERY. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16854482 ↗
• MalfunctionDec 27, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN INSPECTION AT THE LOANER SET DEPARTMENT AT LOC UMKIRCH, IT WAS NOTICED THAT THE ITEM WAS BROKEN. THERE WAS NO IMPACT TO A SURGERY AND THERE WAS NO PATIENT HARM. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXTRACTION SCREW FOR PFNA BLADE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16050243 ↗
• MalfunctionDec 23, 2022Break; Break

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN INSPECTION AT THE LOANER SET DEPARTMENT AT LOC UMKIRCH ON DECEMBER 13, 2022, IT WAS NOTICED THAT THE EXTRACTION SCREW WAS BROKEN. THERE WAS NO SURGERY OR PATIENT IMPACT. THIS REPORT IS FOR AN EXTRACTION SCREW FOR PFNA BLADE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16043507 ↗
• MalfunctionSep 12, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NEW ZEALAND AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT ATTEMPTING TO REMOVE A PFNA; THE REMOVAL TOOL HAD A BROKEN TIP AND WOULD FIT INTO THE PFNA BLADE. CONFUSION AND SURGERY DELAY. OPENED HOSPITAL SET TO GET A NEW REMOVAL TOOL AND SUCCESSFULLY REMOVED PFNA SURGERY WAS DELAY FOR 15 MINUTES BUT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS/ OUTCOME/CONSEQUENCES IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE: UNK - SCREWS: NAIL DISTAL LOCKING (PRODUCT CODE: UNK, LOT NUMBER: UNK, QUANTITY: UNK). THIS REPORT IS FOR ONE (1) EXTRACTSCR F/PFNA BLADE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15401073 ↗
• MalfunctionAug 4, 2022Break; Break

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING INCOMING INSPECTION OF A LOAN KIT, IT WAS DISCOVERED THAT A SECTION OF THE THREADED END OF THE EXTRACTOR IN QUESTION HAD SNAPPED OFF. THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXTRACTION SCREW FOR PFNA BLADE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15166370 ↗
• MalfunctionJul 8, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NEW ZEALAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON INCORRECTLY SIZED THE LENGTH OF THE PFNA BLADE, UPON INSERTING IT WITH THE BLADE INSERTER AND LOCKING OFF THE PFNA BLADE. THEY TOOK AN X-RAY AND NOTED THAT THE BLADE WAS TOO SHORT, THUS THE BLADE NEEDED TO BE REMOVED FOR A LONGER ONE TO BE INSERTED. HOWEVER, SINCE THE BLADE WAS LOCKED, THE EXTRACTOR TOOL NEEDED TO BE USED. WHILE THREADING THIS TOOL INTO THE BLADE TO UNLOCK AND REMOVE IT, THE TOOL THREADS BROKE OFF INTO THE BLADE ITSELF. PLYERS WERE THEN USED TO ROTATE AND UNLOCK THE BLADE MEANING THAT IT COULD BE REMOVED AND REPLACED. THIS REPORT INVOLVES ONE (1) EXTRACTION SCREW FOR PFNA BLADE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14960151 ↗
• InjuryMay 12, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING THE EXPLANTATION OF A PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) BLADE AN EXPLANTATION INSTRUMENT BROKE AND AN EMERGENCY INSTRUMENT SET WAS NEEDED. THE SURGERY WAS DELAYED TO THE NEXT DAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) EXTRACTION SCREW FOR PFNA BLADE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14378421 ↗
• MalfunctionApr 14, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DURING A PROCEDURE THE EXTRACTION SCREW FOR PFNA BLADE BROKE DURING THE OPERATION. THERE WAS NO PATIENT HARM OR THE SURGICAL DELAYS. THIS REPORT IS FOR ONE (1) EXTRACTION SCREW FOR PFNA BLADE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14112559 ↗
• MalfunctionFeb 24, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING A PFNA REMOVAL SURGERY THE INSTRUMENT BROKE. THE BROKEN INSTRUMENT WAS FOUND AFTER THE SURGERY AND DURING THE CLEANING PROCESS. THERE WERE NO FRAGMENTS GENERATED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE REMOVAL PROCEDURE WAS PERFORMED AFTER THE FRACTURE HAD SUCCESSFULLY HEALED AND AT THE PATIENTS REQUEST. THERE WAS NO ADVERSE PATIENT HARM. THIS REPORT INVOLVES ONE (1) EXTRACTSCR F/PFNA BLADE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13591964 ↗
• MalfunctionFeb 14, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENT WAS FOUND TO BE BROKEN. THIS REPORT INVOLVES ONE (1) EXTRACTION SCREW FOR PFNA BLADE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13523892 ↗