MalfunctionGDR
SAW & MICRO SAGISAW
Received May 11, 1995 · Event occurred May 1, 1995
Report 22406 · MDR key 22406
Device
Product problems
- Contamination
- Delivered as Unsterile Product
Patient
71 YR
- Unspecified Infection
Narrative
Description of Event or Problem
DURING PROCEDURE (PODIATRIC) SMALL METAL FRAGMENT DROPPED FROM SAW INTO OPEN WOUND. INSTRUMENT CHECKED BY STERILE SUPPLY AND WAS NOTED TO HAVE BEEN DECONTAMINATED PRIOR TO SURGERY. EQUIPMENT RETURNED TO MFR FOR EVALUATION.