NA 1806-1250SRecalls & reported problems
Stryker GmbH · Guide Wire, Ball-Tipped, sterile · Class 1
Data updated Oct 16, 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 07613153311911), received between Apr 11, 2023 and Apr 11, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Off-Label Use” (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 16, 2026.
Most reported problems
Device problems
- Off-Label Use1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 11, 2023Off-Label Use; Off-Label Use
AS REPORTED: "PRIMARY PROCEDURE, RIGHT SIDE GAMMA NAIL. AFTER OPERATION WAS COMPLETE AND THE BRANCH TRIED TO BILL THE ORDER, A DISPOSABLE OPENED FOR THE CASE WAS UNABLE TO BE BILLED BECAUSE IT WAS EXPIRED. DISCOVERY WAS MADE 12 DAYS POST OP. THE DISPOSABLE CAME INTO CONTACT WITH ANOTHER INSTRUMENT BUT DID NOT COME INTO CONTACT WITH THE PATIENT. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. GUIDE WIRE EXPIRED 28-FEB-2023".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16717898 ↗
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- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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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