NA 204.885Recalls & reported problems
Synthes GmbH · 3.5MM CORTEX SCREW SELF-TAPPING 85MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982146595), received between Nov 20, 2025 and Nov 24, 2025 — classified as 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent8
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
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). WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23631954 ↗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 23630589 ↗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 23630582 ↗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 23630577 ↗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 23630573 ↗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 23630572 ↗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 23630564 ↗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 23610465 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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