NA 03.010.474Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982068958), received between Jun 23, 2017 and Jun 23, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT UNDERWENT AN INITIAL HIP FRACTURE SURGERY. DURING THE SURGERY, THE SURGEON WAS ATTACHING THE NAIL TO THE AIMING ARM AND SAID THAT THE CONNECTING SCREW WAS CROSS-THREADED. THEY TRIED IT TWICE WITH TWO SEPARATE SCREWS, WITH THE SAME CROSS-THREADING PROBLEM. THE SURGEON EXPERIENCED LESS DIFFICULTY WITH THE SECOND SCREW AND WAS ABLE TO COMPLETE THE SURGERY WITH THE SECOND SCREW. THE NAIL WAS SUCCESSFULLY IMPLANTED. THERE WAS NO SURGICAL DELAY. ROUTINE INTRAOPERATIVE X-RAYS WERE TAKEN AS STANDARD FOR THE PROCEDURE. NO PATIENT HARM WAS REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: AIMING ARM (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY OF 1). NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY OF 1). THIS REPORT IS FOR ONE (1) CONNECTING SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6662934 ↗
• MalfunctionJun 23, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT UNDERWENT AN INITIAL HIP FRACTURE SURGERY. DURING THE SURGERY, THE SURGEON WAS ATTACHING THE NAIL TO THE AIMING ARM AND SAID THAT THE CONNECTING SCREW WAS CROSS-THREADED. THEY TRIED IT TWICE WITH TWO SEPARATE SCREWS, WITH THE SAME CROSS-THREADING PROBLEM. THE SURGEON EXPERIENCED LESS DIFFICULTY WITH THE SECOND SCREW AND WAS ABLE TO COMPLETE THE SURGERY WITH THE SECOND SCREW. THE NAIL WAS SUCCESSFULLY IMPLANTED. THERE WAS NO SURGICAL DELAY. ROUTINE INTRAOPERATIVE X-RAYS WERE TAKEN AS STANDARD FOR THE PROCEDURE. NO PATIENT HARM WAS REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: AIMING ARM (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY OF 1). NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY OF 1). THIS REPORT IS FOR ONE (1) CONNECTING SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6662932 ↗