NA 1806-0080SRecalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540195890), received between Dec 15, 2016 and Apr 13, 2020 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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
- Appropriate Device Problem Term/Code Not Available1
- Contamination /Decontamination Problem1
- Device Contaminated During Manufacture or Shipping1
- Device Damaged by Another Device1
- Expiration Date Error1
Patient problems
- No Known Impact Or Consequence To Patient4
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 13, 2020Device Damaged by Another Device; Device Damaged by Another Device
THE CUSTOMER REPORTED THAT : "THE GUIDE ROD IS DAMAGED BY THE REAMER DURING THE OPERATION ON THE TIBIAL SHAFT , THE GUIDE ROD N1 THEN N2 WERE ALTERED BY THE REAMER, OR POSSIBLE DEFECT NOT VISIBLE TO THE NAKED EYE NOR TO THE OPERATING TEAM'S TOUCH. CONSEQUENCES: METAL DEBRIS ON REAMERS, ROD CHANGE, BROKEN REAMER."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9954992 ↗MalfunctionDec 23, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED, DURING AN IN-COMING INSPECTION AT DISTRIBUTION, IT WAS FOUND THAT THERE WAS A FOREIGN MATERIAL (HAIR) IN BLISTER PACKAGE. THIS EVENT WAS FOUND ON (B)(4) UNITS WITH LOT#K0AC0B4.
Patient problems: No Patient Involvement
MAUDE report 9513692 ↗MalfunctionApr 4, 2019Expiration Date Error
IT WAS REPORTED THAT THE HOSPITAL OPENED AN EXPIRED GUIDE WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO ADVERSE CONSEQUENCES OR SURGICAL DELAY WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8483031 ↗MalfunctionDec 1, 2018Appropriate Device Problem Term/Code Not Available
IN IN-COMING INSPECTION AT DISTRIBUTION, IT WAS FOUND THAT THERE WAS A FOREIGN MATERIAL (HAIR / BUG) IN BLISTER. THIS EVENT WAS FOUND ON 1 OF 50PCS OF 18060080S, LOT# K0B324F RECEIVED ON OUR PO#(B)(4) AND 1 OF 100PCS OF 18060085S, LOT# K09A2F3 RECEIVED ON OUR PO#(B)(4). NO PATIENT INVOLVEMENT, ADVERSE CONSEQUENCES, DELAY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8121799 ↗MalfunctionDec 15, 2016Device Contaminated During Manufacture or Shipping
IN IN-COMING INSPECTION AT DISTRIBUTION CENTER, IT WAS FOUND THAT THERE WAS A FOREIGN MATERIAL (FIBER) IN PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 6175909 ↗
Other Guide, Surgical, Instrument devices
- NA 03.037.017Synthes GmbH · Guide, surgical, instrument346 reports
- EVOS 71174934Smith & Nephew, Inc. · Guide, surgical, instrument149 reports
- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
- DJO SURGICAL 342-10-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall51 reports
- DJO SURGICAL 341-10-707Encore Medical, L.P. · Guide, Surgical, Instrument81 reports
- NA 03.010.404Synthes GmbH · Guide, surgical, instrument73 reports
- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
- DJO SURGICAL 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 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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