NA 03.168.002Recalls & reported problems
Synthes GmbH · CORRECTION GUIDE FOR 3.2MM GUIDE WIRES · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982274472), received between Jan 24, 2020 and Aug 4, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- 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.
MalfunctionAug 4, 2025Break; Break
IT WAS REPORTED DURING A PROCEDURE THE FEMORAL NECK SYSTEM (FSN) MISSED THE TARGETER COMPLETELY; THE DRILL WAS SET TO 95MM BUT OVERDRILLED TO 100MM. THERE WAS NO IMPACT ON THE PATIENT. IT WAS NOTED THERE WAS RUST ON THE FSN ITEMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22701503 ↗MalfunctionJul 29, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE THERE WAS RUST ON FEMORAL NECK SYSTEM (FNS) ITEMS, AND NEED REPLACING DUE TO FNS DRILL BIT HITTING. THE X2 CANNULATED SCREWS BROKE WHILE INSERTING IN FEMORAL NECK. THE SCREW (03.354.460) BROKE IN FEMORAL NECK. IT SNAPPED IN HALF WHILE INSERTING. THE FNS MISSED THE TARGETER COMPLETELY AND WHENEVER WE SET THE DRILL TO 95MM IT OVER DRILLED TO 100MM. IT KEPT SLIDING FOR SOME REASON. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS RELATED TO (B)(4) WHICH CAPTURES ADDITIONAL REPORTED DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22651221 ↗MalfunctionJan 24, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2020 DURING AN UNKNOWN PROCEDURE THE TIP OF THE CORRECTION GUIDE FOR GUIDE WIRES WAS BENT AND DID NOT ACCEPT THE GUIDE WIRE. THERE WAS NO SURGICAL DELAY. THE CASE WAS COMPLETED WITHOUT ANY PROBLEMS OR DELAY. A BACK UP DEVICE WAS USED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE: UNKNOWN GUIDE WIRE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE CORRECTION GUIDE FOR 3.2MM GUIDE WIRES. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9629442 ↗
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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