NA 03.019.026Recalls & reported problems
Synthes GmbH · 2.5MM GUIDE ROD W/STOP TROCAR TIP/230MM · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982069658), received between Aug 6, 2024 and Dec 18, 2025 — classified as 4 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 Device2
- Device Slipped1
Patient problems
- Foreign Body In Patient2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 18, 2025Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT THE GUIDE WAS DAMAGED DURING THE PROCEDURE. A FRAGMENT OF THE INITIATOR GUIDE REMAINED IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 23837370 ↗MalfunctionNov 3, 2025Break; Entrapment of Device; Break; Entrapment of Device
WHEN PERFORMING THE ENTRY POINT THE SPECIALIST IGNORED THE INDICATION THAT HE MUST ALIGN THE STARTER BIT WITH THE GUIDE. THEREFORE WHEN PRESSURE WAS APPLIED WITH THE MOTOR IT BENT AND BROKE, LEAVING PART OF IT IN THE PATIENT. PART OF THE GUIDE REMAINED IN THE PROXIMAL HUMERUS AND COULD NOT BE REMOVED.
Patient problems: Foreign Body In Patient
MAUDE report 23457401 ↗MalfunctionApr 21, 2025Device Slipped; Device Slipped
IT WAS REPORTED THAT THE SMALL STOP BUTTON ON THE GUIDE ROD PULLED OFF CAUSING DELAY AND REWORK OF THE ENTRY POINTS. THE AIMING WAS DONE WITH THE PIN. THE SPINDLE BUSHING HAS LOOSENED DURING THE PROCEDURE. THE PIN WAS PUSHED TOO FAR + 20 CM. THE AIM WAS NO LONGER GOOD. THE SURGEON HAD TO REMOVE AND REDO. THE BOLT WAS ALMOST LOST IN THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIFTEEN MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21872499 ↗MalfunctionAug 6, 2024Break; Break
IT WAS REPORTED THE TIP OF THE GUIDE ROD BROKE DURING INSERTION TO THE PATIENT¿S BONE. THE SURGEON MANAGED TO RETRIEVE THE BROKEN PIECE AND PROCEED WITH THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A THIRTY (30) MINUTE DELAY AND NO CONSEQUENCES TO THE PATIENT. THIS REPORT IS FOR A GUIDE ROD. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19919548 ↗
Other Guide, surgical, instrument devices
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- 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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