NA 03.037.140Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982070593), received between Jun 25, 2019 and Feb 17, 2021 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2021Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SCREW INSERTER WAS DEFORMED. UPON INSERTION OF THE LAG SCREW USING THE SCREW INSERTER THE INSERTION T HANDLE DEVICE BECAME UNATTACHED FROM THE LAG SCREW AND PREVENTED FURTHER INSERTION. THE T HANDLE INSERTER AND COUPLING SCREW WERE INSPECTED AND SEEMED TO BE DISFIGURED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE OUTCOME WAS UNKNOWN. NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: HELICAL BLADE/SCREW COUPLING SCREW (PART: 03.037.026; LOT:3L89171; QUANTITY: 1). SCREW INSERTER (PART NUMBER 03.037.025, LOT UNKNOWN, QUANTITY 1). SCREWS: LAG (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) LOCKING DEVICE FOR SCREW ONLY AIMING ARM. THIS IS REPORT 2 OF 4 FOR (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11337326 ↗
• MalfunctionAug 13, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, ONE LOCKING DEVICE FOR SCREW ONLY AIMING ARM WAS BROKEN DUE TO WEAR AND TEAR. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) LOCKING DEVICE FOR SCREW ONLY AIMING ARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10404381 ↗
• MalfunctionJun 24, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, A DRIVING CAP AND TWO (2) LOCKING DEVICE FOR SCREW ONLY AIMING ARM WERE FOUND BROKEN AT THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) LOCKING DEVICE FOR SCREW ONLY AIMING ARM. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10192312 ↗
• MalfunctionJun 24, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, A DRIVING CAP AND TWO (2) LOCKING DEVICE FOR SCREW ONLY AIMING ARM WERE FOUND BROKEN AT THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) LOCKING DEVICE FOR SCREW ONLY AIMING ARM. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10192304 ↗
• MalfunctionNov 21, 2019Break; Break

  UPDATED CONCOMITANT DEVICE REPORTED: UNKNOWN HANDLE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9355407 ↗
• InjuryJun 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN (B)(6) IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A FEMORAL NAILING SURGERY WITH THE RIGHT TROCHANTERIC FEMORAL NAILING SYSTEM ADVANCED (TFNA) INTRAMEDULLARY NAIL FOR A SUB-TROCHANTERIC FEMORAL FRACTURE ON (B)(6) 2019. THE FRACTURE WAS DIFFICULT TO REDUCE. BEFORE IMPLANTATION, THE NURSING STAFF AND THE SURGEON TESTED TO INSERT THE LAG SCREW INTO THE NAIL AND HAD NO ISSUES WITH THE JIG. DURING IMPLANTATION, THE NAIL AND LAG SCREW WAS IMPLANTED WITH SOME DIFFICULTY IN THE INSERTION OF THE NAIL. DISTAL CROSS BOLTS WERE THEN IMPLANTED AND THE JIG WAS REMOVED. IN THE FINAL SHOTS, THE SCREW APPEARED TO HAVE MISSED THE NAIL. THE SURGEON REMOVED THE LAG SCREW AND THEN WITH THE ASSISTANCE OF ANOTHER SURGEON REINSERTED THE LAG SCREW AFTER CONNECTING THE JIG INTO THE NAIL IN-SITU. X-RAYS WERE THEN TAKEN AND WAS CONFIRMED THAT THE LAG SCREW WAS SUCCESSFULLY RE-POSITIONED TO THE NAIL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 45 MINUTES. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN TFNA NAIL (PART # 04.037.028S, LOT # H309035, QUANTITY# 1). LOCKING SCREW (PART# 04.005.530S, LOT# 2L43586, QU

  Patient problems: No Code Available

  MAUDE report 8730621 ↗