NA 360.266Recalls & reported problems
Synthes GmbH · 1.6MM WIRE GUIDE FOR 3.7MM CANNULATED LOCKING SCREWS · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982197603), received between Nov 16, 2021 and Dec 14, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device-Device Incompatibility2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 14, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROXIMAL HUMERUS, THE SURGEON HAD DIFFICULTIES GETTING THE WIRE GUIDE SLEEVE FOR 3.7 CANNULATED SCREWS TO THREAD INTO THE PLATE. ULTIMATELY, HE SWITCHED TO USING A REGULAR LOCKING TO WE, A WIRE SLEEVE TO MEASURE THE SCREW AND PLACED IT SUCCESSFULLY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH FIVE(5) MINUTES SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 1.6 WIRE GUIDE FOR 3.7 CANN LCKNG SCREWS. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13003885 ↗MalfunctionNov 16, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROXIMAL HUMERUS, THE SURGEON HAD DIFFICULTIES GETTING THE WIRE GUIDE SLEEVE FOR 3.7 CANNULATED SCREWS TO THREAD INTO THE PLATE. ULTIMATELY, HE SWITCHED TO USING A REGULAR LOCKING TO WE, A WIRE SLEEVE TO MEASURE THE SCREW AND PLACED IT SUCCESSFULLY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH FIVE(5) MINUTES SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 1.6 WIRE GUIDE FOR 3.7 CANN LCKNG SCREWS. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12820730 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.