NA 204.860Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982146502), received between Jan 16, 2018 and Nov 20, 2025 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHILE AUDITING A SCREW CADDY, SCREWS WERE FOUND TO BE DAMAGED. THE SCREW THREADS SEEMED FILED DOWN AND COULD NOT BE USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610444 ↗
• MalfunctionNov 20, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHILE AUDITING A SCREW CADDY, SCREWS WERE FOUND TO BE DAMAGED. THE SCREW THREADS SEEMED FILED DOWN AND COULD NOT BE USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610443 ↗
• MalfunctionNov 20, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHILE AUDITING A SCREW CADDY, SCREWS WERE FOUND TO BE DAMAGED. THE SCREW THREADS SEEMED FILED DOWN AND COULD NOT BE USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610441 ↗
• MalfunctionNov 20, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHILE AUDITING A SCREW CADDY, SCREWS WERE FOUND TO BE DAMAGED. THE SCREW THREADS SEEMED FILED DOWN AND COULD NOT BE USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610438 ↗
• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS SUBMITTED AS PART OF AN INVESTIGATOR INITIATED STUDY (IIS) FOR THE RETROGRADE FEMORAL NAIL ADVANCED (RFNA). IT WAS REPORTED THAT A PATIENT WAS PRESENTED AFTER A MOTOR VEHICLE CRASH WITH A LEFT OPEN DISTAL FEMUR FRACTURE ON (B)(6) 2021 AND WAS OPERATED ON WITH RFNA INTRAMEDULLARY NAIL ON (B)(6) 2021. PATIENT WAS DIAGNOSED WITH INFECTION OF HER HARDWARE/SEPTIC NONUNION ON (B)(6) 2021. PATIENT UNDERWENT DEBRIDEMENT AND EXCHANGE OF HARDWARE ON (B)(6) 2021. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 60MM. THIS IS REPORT 7 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 15643869 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT WAS INVOLVED IN AN INCIDENT AT WORK THAT RESULTED IN MULTIPLE INJURIES, ONE OF WHICH WAS A FRACTURE TO HIS ARM. TO REPAIR THE FRACTURE, THE SURGEON PLACED AN IMPLANT IN THE PATIENT'S ARM. ON (B)(6) 2019, THE IMPLANT BROKE CAUSING ANOTHER FRACTURE TO THE PATIENT'S ARM. ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION PROCEDURE TO REMOVE THE BROKEN IMPLANT. THIS IS REPORT 11 OF 17 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 14090414 ↗
• InjuryJan 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A DERMATOLOGIST TAKING CARE OF A PATIENT WITH SEVERE RASH POSSIBLY RELATED TO METAL ALLERGY. HE HAS A COBALT ALLERGY AND QUESTIONABLE GOLD ALLERGY. HE HAD SURGERY IN 2018 AND HAD TWO OF YOUR SCREWS, PER THE OP RECORD OF A ONE (1) 3.5MM CORTEX SCREW, SELF-TAPPING AND ONE (1) 3.5MM STAINLESS STELL CORTEX SCREW, SELF-TAPPING WITH HEX RECESS. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 60MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 13237128 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, THE HARDWARE IN QUESTION WAS REMOVED DUE TO INFECTION. IT IS UNKNOWN WHEN THE HARDWARE WAS ORIGINALLY IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 60MM. THIS IS REPORT 9 OF 11 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12489478 ↗
• InjuryMay 17, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT HARDWARE REMOVAL DUE TO THE CORTEX SCREW SELF-TAPPING 60MM THAT WAS USED AS A SYNDESMOSIS SCREW THAT WAS BROKE. THE SCREW SHAFT REMAINED IN THE TIBIA. ORIGINAL IMPLANTATION DATE WAS ON (B)(6) 2018. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNKNOWN LONG CORTICAL SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1)- 3.5MM CORTEX SCREW SELF-TAPPING 60MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8620086 ↗
• InjuryJan 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Code Available; Pain

  MAUDE report 7195442 ↗