MY3D PATIENT SPECIFIC CASE
Received Jul 27, 2026 · Event occurred Jun 22, 2026
Report 3013450937-2026-00263 · MDR key 50002143
Device
Product problems
- Lack of Effect
Patient
76 YR · Female
- Insufficient Information
Narrative
Description of Event or Problem
It was reported there was a delay in surgery as the surgeon was having issues with the position of the guide handles. Handles were too inferiorly positioned relative to surgeon's exposure window causing difficulties with the handle interfering with retractors. Drill guide handle had to be removed intra-operatively for the guide to be utilized. Corresponds to case number (b)(4), Glenoid Drill Guide.
Additional Manufacturer Narrative
The root cause of this complaint was determined to be the positioning of the guide handles. Handles may be improved in design at a true 9 o'clock or 3 o'clock position, depending on the operative side.