NA 204.895Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982146618), received between Sep 15, 2023 and Nov 25, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON AN UNKNOWN DATE THAT WHILE AUDITING A SCREW CADDY, THESE SCREWS WERE FOUND TO BE DAMAGED. THE SCREW THREADS SEEMED FILED DOWN AND COULD NOT BE USED. THERE WAS NO PATIENT INVOLVEMENT. (B)(4), (B)(4) AND (B)(4) ARE RELATED TO EACH OTHER. (B)(4) AND (B)(4) WERE CREATED TO CAPTURE ADDITIONAL IPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23643487 ↗
• MalfunctionNov 25, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON AN UNKNOWN DATE THAT WHILE AUDITING A SCREW CADDY, THESE SCREWS WERE FOUND TO BE DAMAGED. THE SCREW THREADS SEEMED FILED DOWN AND COULD NOT BE USED. THERE WAS NO PATIENT INVOLVEMENT. (B)(4), ARE RELATED TO EACH OTHER. (B)(4) WERE CREATED TO CAPTURE ADDITIONAL IPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23643485 ↗
• MalfunctionNov 25, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON AN UNKNOWN DATE THAT WHILE AUDITING A SCREW CADDY, THESE SCREWS WERE FOUND TO BE DAMAGED. THE SCREW THREADS SEEMED FILED DOWN AND COULD NOT BE USED. THERE WAS NO PATIENT INVOLVEMENT. (B)(4) ARE RELATED TO EACH OTHER. (B)(4) WERE CREATED TO CAPTURE ADDITIONAL IPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23643475 ↗
• MalfunctionNov 25, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON AN UNKNOWN DATE THAT WHILE AUDITING A SCREW CADDY, THESE SCREWS WERE FOUND TO BE DAMAGED. THE SCREW THREADS SEEMED FILED DOWN AND COULD NOT BE USED. THERE WAS NO PATIENT INVOLVEMENT. PC-(B)(4) ARE RELATED TO EACH OTHER. PC-(B)(4) WERE CREATED TO CAPTURE ADDITIONAL IPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23643469 ↗
• MalfunctionNov 24, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON AN UNKNOWN DATE THAT WHILE AUDITING A SCREW CADDY, THESE SCREWS WERE FOUND TO BE DAMAGED. THE SCREW THREADS SEEMED FILED DOWN AND COULD NOT BE USED. THERE WAS NO PATIENT INVOLVEMENT. (B)(4) IS LINKED TO (B)(4) WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632004 ↗
• MalfunctionNov 24, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON AN UNKNOWN DATE THAT WHILE AUDITING A SCREW CADDY, THESE SCREWS WERE FOUND TO BE DAMAGED. THE SCREW THREADS SEEMED FILED DOWN AND COULD NOT BE USED. THERE WAS NO PATIENT INVOLVEMENT. (B)(4) IS LINKED TO (B)(4) WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630728 ↗
• MalfunctionNov 24, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON AN UNKNOWN DATE THAT WHILE AUDITING A SCREW CADDY, THESE SCREWS WERE FOUND TO BE DAMAGED. THE SCREW THREADS SEEMED FILED DOWN AND COULD NOT BE USED. THERE WAS NO PATIENT INVOLVEMENT. (B)(4) IS LINKED TO (B)(4) WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630725 ↗
• 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 23610466 ↗
• InjurySep 15, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2008, THE PATIENT HAD CAR/CAR COLLISION AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT UNDERWENT SEVERAL SURGERIES FOR ORTHOPEDIC INJURIES INCLUDING AN OPEN REDUCTION INTERNAL FIXATION FOR A FRACTURE-DISLOCATION OF HIS FEMORAL HEAD AND NECK AND A SACROILIAC SCREW FIXATION AND ANTERIOR PUBIC PLATE FOR MALGAIGNE FRACTURE. ON (B)(6) 2008 THE PATIENT UNDERWENT ORIF LEFT FEMORAL HEAD, ORIF LEFT FEMORAL NECK, ORIF LEFT ANTERIOR COLUMN ACETABULUM, ORIF PUBIC SYMPHYSIS (SYNTHES PELVIC PLATE ACROSS HIS PUBIS EXTENDING TO THE LEFT HIP) AND PERCUTANEOUS ILIOSACRAL SCREW FIXATION DUE TO LEFT ACETABULAR FRACTURE AND LEFT FEMORAL HEAD FRACTURE. ON (B)(6) 2010 THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY WITH DEPUY COMPONENTS DUE TO HIP PAIN, METALLOSIS, TRAUMATIC ARTHRITIS LEFT HIP WITH FEMORAL HEAD AVASCULAR NECROSIS AND NONUNION FEMORAL HEAD FRACTURE, MALGAIGNE FRACTURE AND INTRAARTICULAR HARDWARE BROKE WITH SCREWS. THIS REPORT INVOLVES ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 95MM. THIS IS REPORT 1 OF 10 FOR (B)(4). THIS PRODUCT COMPLAINT IS RELATED TO (B)(4). (B)(4) CAPTURES ADDITIONAL IMPACTED PRODUCTS RELATED TO THIS EVENT.

  Patient problems: Foreign Body Reaction; Necrosis; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 17754878 ↗