Ti Screw ESRecalls & reported problems across all models
Biomet Orthopedics, LLC · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 0
We found 4 models of Ti Screw ES by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Oct 22, 2020 and Dec 5, 2025 — classified as 7 injuries, 15 malfunctions.
The most frequently reported specific device problem is “Fracture” (22 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Ti Screw ES problems
Device problems
- Fracture22
- Failure to Advance2
- Material Twisted/Bent2
- Off-Label Use2
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- Foreign Body In Patient7
- Failure of Implant5
- No Consequences Or Impact To Patient2
Ti Screw ES models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Ti Screw ES 902569FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE9 reports
- Ti Screw ES 902571FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE5 reports
- Ti Screw ES 902572Screw, fixation, bone5 reports
- Ti Screw ES 902570FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE3 reports
Recent Ti Screw ES adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionApr 14, 2025Fracture; Fracture
IT WAS REPORTED THAT WHILE THE SURGEON WAS ATTEMPTING TO INSERT THE IMPLANT INTO THE PATIENT'S ROTATOR CUFF, THE IMPLANT FRACTURED. ALL PIECES AND FRAGMENTS OF THE IMPLANT WERE REMOVED FROM THE PATIENT. THERE WAS NO FOREIGN BODY RETAINED OR HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21833901 ↗MalfunctionOct 15, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20450593 ↗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 ↗InjuryFeb 12, 2024Fracture; Fracture
NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.
Patient problems: Foreign Body In Patient
MAUDE report 18685764 ↗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 25, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18002646 ↗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 ↗InjuryJul 11, 2023Fracture; Fracture
IT WAS REPORTED THAT THE ANCHOR FRACTURED DURING THE PROCEDURE. A PIECE OF THE ANCHOR WAS RETAINED BY THE PATIENT. THE PROCEDURE HAD TO BE COMPLETED WITH A LARGER IMPLANT TO COMPENSATE FOR THE MISSING PIECE OF THE TENDON SUTURE ANCHOR.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 17297463 ↗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 ↗MalfunctionJun 9, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 17097970 ↗MalfunctionFeb 28, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING ARTHROSCOPIC SURGERY IN THE SHOULDER JOINT, THE ANCHOR BROKE WHILE SCREWING INTO THE HUMERUS. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16454116 ↗
Other Biomet Orthopedics, LLC products
- AFFIXUSHIP FRACTURE NAIL - RIGHT39 models · 6 reports · 37 recalls
- AFFIXUSHIP FRACTURE NAIL - LEFT27 models · 7 reports · 24 recalls
- Compress Device71 models · 99 reports · 22 recalls
- Arcos Modular Revision Hip System71 models · 191 reports · 19 recalls
- Comprehensive Reverse Shoulder57 models · 895 reports · 3 recalls
- Vanguard Knee System147 models · 306 reports · 13 recalls
- STAGEONE17 models · 0 reports · 18 recalls
- StageOne Select15 models · 2 reports · 15 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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