NA 02.113.001Recalls & reported problems
Synthes GmbH · 1.6MM DRILL TIP GUIDE WIRE 200MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982034717), received between May 20, 2020 and May 20, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
- Entrapment of Device1
Patient problems
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 20, 2020Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE A 30MM PORTION OF THE 1.6 DRILL TIP GUIDE WIRE WAS RETAINED IN THE PATIENT'S RIGHT MIDSHAFT TIBIA. THERE WAS NO SURGICAL DELAY REPORTED. THERE WAS NO ADVERSE EFFECT DURING THE SURGERY. PATIENT STATUS WAS STABLE. THIS REPORT INVOLVES ONE (1) 1.6MM DRILL TIP GUIDE WIRE 200MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Injury
MAUDE report 10075409 ↗
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- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 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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