Ti Screw ES 902569Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of Ti Screw ES (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00880304432093), received between Apr 26, 2021 and Dec 5, 2025 — classified as 2 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Fracture” (9 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
- Fracture9
- Off-Label Use2
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Foreign Body In Patient2
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryDec 5, 2025Fracture; Off-Label Use; Fracture; Off-Label Use
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 23727445 ↗InjuryDec 5, 2025Fracture; Off-Label Use; Fracture; Off-Label Use
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 23727443 ↗MalfunctionMar 25, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE, THE ANCHOR FRACTURED. NO PATIENT HARM OCCURRED AS A RESULT OF THE EVENT AND THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18975853 ↗MalfunctionDec 29, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18420838 ↗MalfunctionOct 23, 2023Fracture; Fracture
IT WAS REPORTED THAT THE ANCHOR WAS FRACTURED DURING THE SURGERY. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17985236 ↗MalfunctionSep 18, 2023Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT FRACTURED DURING THE PROCEDURE. ALL PIECES WERE REMOVED FROM THE PATIENT'S WOUND AND A SECOND ANCHOR WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17763759 ↗MalfunctionJul 25, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING THE PROCEDURE, THE ANCHOR FRACTURED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17388581 ↗MalfunctionJun 26, 2023Fracture; Fracture
IT WAS REPORTED THAT THE PACKAGE WAS INTACT, AND DURING THE SURGERY, THE PACKAGE WAS OPENED, AND THE PRODUCT WAS HANDED TO THE INSTRUMENTATION NURSE. THEN THE MAIN SURGEON FIRST USED A 2.0 K-WIRE TO OPEN THE SCREW CHANNEL, AFTER WHICH, AN ANCHOR SCREW WAS IMPLANTED, AND AFTER SCREWING 2/3 OF THE ANCHOR SCREW, A SUDDEN FRACTURE OCCURRED. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17198032 ↗MalfunctionApr 26, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11723792 ↗
Other FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE devices
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- HEALICOIL 72205137Smith & Nephew, Inc. · Fastener, fixation, biodegradable, soft tissue427 reports
- HEALIX ADVANCE ORTHOCORD 222296Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE320 reports
- TWINFIX 72202597Smith & Nephew, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE288 reports
- Arthrex® AR-2324BCCArthrex, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE254 reports
- HEALIX ADVANCE 222331Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall196 reports
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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