Cannulated Compression Headless Screw 03.333.300Recalls & reported problems
Tyber Medical, LLC · T6 CANN STRDRV SCRWDRVR SHAFT SLF-RETAIN · Class 1
All models of Cannulated Compression Headless Screw (21)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00819917026856), received between Jul 28, 2022 and Jul 28, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Align” (1 report).
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 18, 2026.
Most reported problems
Device problems
- Failure to Align1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2022Failure to Align; Failure to Align
THE SCREWDRIVER REFERENCE 03.333.300 OF THE CCHS 2.0 TECHNIQUE DOES NOT ANCHOR IN THE HEAD OF THE SCREW REFERENCE 04.333.030TS WITH LOT NUMBER 215913 AT THE TIME OF SURGERY. WE DO NOT KNOW IF IT IS A PROBLEM WITH THE SCREW OR THE SCREWDRIVER. CUSTOMER REFERENCE/PO/SERVICE: (B)(6), WAS SURGERY. DELAYED DUE TO THE REPORTED EVENT? YES, IF YES, NUMBER OF MINUTES: 60. ACTION TAKEN WHEN EVENT OCCURRED? CAMBIO DE TÉCNICA QUIRÚRGICA. WAS PROCEDURE SUCCESSFULLY COMPLETED? NO. WERE FRAGMENTS GENERATED? NO. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. IF NO, EXPLAIN: NO HABÍA MÁS UNIDADES DE LA REFERENCIA DEL TORNILLO REQUERIDA. PATIENT STATUS/ OUTCOME / CONSEQUENCES. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY?: NO. IP-01469889 DEVICE PROPERTY OF: OTHER. DEVICE IN POSSESSION OF: (B)(6). BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE. THIS COMPLAINT INVOLVES ONE (1) DEVICE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15122778 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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