JOSEPH DOUBLE HOOK 5MM
Received Jan 19, 2018 · Event occurred Sep 26, 2017
Report 9611112-2018-00001 · MDR key 7206053
Device
Product problems
- Fracture
- Fracture
Patient
45 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED WITH THE BROKEN-OFF TIP. IT HAD BEEN MANUFACTURED IN AUGUST 2011. REVIEW OF MANUFACTURING RECORDS CONFIRMED DEVICE CONFORMANCE TO SPECS AT TIME OF RELEASE. HARDNESS OF RETURNED DEVICE WAS TESTED AND FOUND CONFORMING TO SPECIFICATIONS. THE DEVICE WAS SUBJECT TO MICROSCOPIC EXAMINATION. IT SHOWED EVIDENCE OF EXTENSIVE REUSE, SUCH AS WEAR, SCRATCHES, AND STAINING IN THE FRACTURE AREA. THEREFORE, FRACTURE DUE TO EXCESSIVE WEAR AND TEAR SEEMS TO BE THE MOST PROBABLE CAUSE.
Description of Event or Problem
DURING AN OPEN REDUCTION WITH INTERNAL FIXATION OF THE RIGHT INDEX FINGER, THE TIP OF THE INSTRUMENT BROKE OFF. THE BROKEN PIECE WAS RETRIEVED. NO DELAY OR INJURY DURING CASE.