NA 03.010.201Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982068040), received between Nov 15, 2017 and Jun 28, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: THIS PC IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE DEFECTS ON THE REPLACEMENTS. THIS PC REPORTS ABOUT THE DEVICES WHICH NEEDED TO BE REPLACED DUE TO SOME DEFECTS. IT WAS REPORTED THAT THE PRINTINGS ON THE SURFACE OF SOME DEVICES BECAME FAINT OR SHAVED DUE TO AGING, AND THE SURELOCK CONNECTOR WAS BROKEN. THE HOSPITAL REQUESTED REPLACEMENTS FOR THOSE DEVICES. SINCE THE DEVICES WITH FAINTED PRINTING AND SHAVED SURFACES AND BROKEN SURELOCK CONNECTOR ARE COMPONENTS OF AN INSTRUMENT SET FOR A PFNA SURGERY AND THE SPECIFIC PRODUCT CODES ARE UNKNOWN, WE REGISTER 03.010.065, 03.010.200 AND 03.010.201 TEMPORALLY AS IMPACTED PRODUCTS. THE INSTRUMENT SET INCLUDING THE IMPACTED PRODUCTS HAVE BEEN OUTSOURCED TO THE HOSPITAL FOR SEVERAL YEARS. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) SURELOCK CONNECTOR LE F/LONG PROX-FEMNAI. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14842545 ↗
• MalfunctionNov 15, 2017Failure to Align; Failure to Align

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE REPORTED DEVICE WAS USED IN THE SURGERY FOR THE FEMORAL TROCHANTERIC FRACTURE ON (B)(6) 2017. THE TFNA NAIL (LONG) WAS USED FOR THE PROCEDURE. WHEN THE SURGEON TRIED TO DRILL THE HOLE FOR THE DISTAL LOCKING SCREW BY USING THE SURELOCK AIMING ARM FOR ANTEGRADE FEMORAL NAILS, THE DRILL BIT INTERFERED WITH THE NAIL. IT WAS FOUND THAT THE CONNECTING PART OF THE SURELOCK AIMING ARM TO THE HANDLE HAD BEEN LOOSE. ONE OF THE THREE PROJECTED PARTS ON THE AIMING ARM, WHICH WERE ALL SUPPOSED TO BE FIXED USUALLY, HAD NOT BEEN FIXED (IT WAS RECESSED). THE SURGERY WAS EXTENDED FOR SIXTY (60) MINUTES. NO ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED, PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE: TFNA NAIL LONG (QUANTITY 1), DRILL BIT (QUANTITY 1). THIS REPORT IS FOR ONE (1) SURELOCK CONNECTOR-LEFT ANTEGRADE FEMORAL NAILS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7034489 ↗