T2 ALPHA 2351-3100SRecalls & reported problems
Stryker GmbH · Guide Wire with Ruler Tube · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327361803), received between Feb 9, 2024 and Feb 9, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Mar 28, 2025Open, Classified
The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
Z-1621-2025 · Root cause: Device Design · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED: "T2 ALPHA GUIDEWIRE MEASURING TUBE METAL CAP DEBONDED IN PATIENT¿S LEG AND HAD TO BE REMOVED WITH FORCEPS. NO REPLACEMENT ITEM WAS USED.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18675017 ↗MalfunctionFeb 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED: "A COMPLAINT WAS REPORTED THIS MORNING WITH RESPECT TO THE GUIDE WIRE RULER TUBES. DURING USAGE, THE SURGEON REPORTS THAT THE METAL COMPONENT ON THE BOTTOM END OF THE GUIDE WIRE RULER TUBE WAS DETACHED FROM THE DEVICE INTRAOPERATIVELY, LEAVING THE METAL COMPONENT FREE FLOATING IN THE INCISION SITE AROUND THE KNEE. USED NEW GUIDE WIRE MEASURING TUB AND THE SILVER CAP DEBONDED. NO REPLACEMENT DEVICE WAS USED. THE RING LOOSENED DURING THE REMOVAL OF THE MEASURING TUBE THROUGH THE METAL 8-11 ALPHA TIBIA SUPRAPATELLAR SLEEVE. I DON¿T RECALL THE RING GETTING CAUGHT ON ANY BONE. THE RING WAS REMOVED DURING THE SURGERY.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18674984 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.