MalfunctionHTS
SYNTHES (FRA)
Received Jun 7, 1999 · Event occurred Jun 4, 1999
Report MW1016543 · MDR key 227725
Device
Generic name
Distarctor Blade
Manufacturer
Synthes UsaModel number
*Catalog number
397.013
Lot number
A7HA12
Product problems
- Break
- Device, or device fragments remain in patient
- Difficult to Remove
Patient
76 YR
- Nonresorbable materials, unretrieved in body
- Foreign body, removal of
- Therapy/non-surgical treatment, additional
- Surgical procedure, additional
Narrative
Description of Event or Problem
SYNTHES FRA DISTRACTER BLADE WAS BROKEN OFF DURING SURGICAL PROCEDURE. SURGEON WAS PRESENT AND OPERATING FAULTY DEVICE DURING OCCURRENCE. X-RAY WAS TAKEN. AN ATTEMPT TO REMOVE BROKEN INSTURMENT WAS UNSUCCESSFUL AT THIS TIME. THE PT WILL RETURN FOR SURGERY ONE WEEK FROM NOW FOR A POSTERIOR FUSION AT WHICH TIME THE BROKEN INSTRUMENT WILL BE REMOVED.