NA 254417Recalls & reported problems
Medos International Sàrl · Nitinol Guidewire 1.1mm x 22.9cm (9 Inches) · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20886705012913), received between Jul 3, 2018 and Dec 1, 2023 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (3 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, 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
Most reported problems
Device problems
- Break3
- Entrapment of Device1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 1, 2023Break; Break
IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGICAL PROCEDURE PERFORMED ON(B)(6) 2023 IT WAS OBSERVED THAT THE NITINOL OF THE ACL ACC G-W NTNL 9X.042" *PK/6 GUIDE BROKE DURING SCREWING OF THE TIBIA. IT WAS REPORTED THAT THERE WAS A 15-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS REPORTED THAT FRAGMENTS WERE GENERATED AND WERE NOT EASILY REMOVED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18249114 ↗InjuryOct 5, 2018Break; Entrapment of Device; Break; Entrapment of Device
ADDITIONAL INFORMATION RECEIVED FROM AFFILIATE ON 26OCTOBER2018: IT WAS REPORTED THE DEVICE WILL BE AVAILABLE TO RETURN TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Foreign Body In Patient
MAUDE report 7938269 ↗MalfunctionJul 3, 2018Break; Break
THE GUIDEWIRE BROKE INSIDE THE SCREW DRIVER WHILE SCREWING THE MILAGRO. ALL PARTS CAME OUT. NO ISSUE FOR PATIENT. REPLACED WITH ANOTHER GUIDE WIRE. EXTRA SURGERY TIME: 10 MIN. SURGERY: ACL RECON. HAMSTRINGS GRAFT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7658966 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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