LEWIN BONE HOLD CLAMP 7
Received Mar 31, 2017
Report 9611112-2017-00001 · MDR key 6449076
Device
Product problems
- Fracture
- Fracture
Patient
30 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED WITHOUT THE BROKEN-OFF TIP. IT HAD BEEN MANUFACTURED IN 2012. 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. SINCE THE DEVICE WAS RETURNED INCOMPLETE, I.E., WITHOUT THE BROKEN-OFF TIP, IT IS NOT POSSIBLE TO REACH A DEFINITE CONCLUSION WITH REGARD TO THE CAUSE OF THE FRACTURE. HOWEVER, FRACTURE DUE TO EXCESSIVE WEAR AND TEAR SEEMS TO BE THE MOST PROBABLE CAUSE.
Description of Event or Problem
DURING AN OPEN REDUCTION (INTERNAL FIXATION OF THE PROXIMAL HUMERUS), THE TIP OF THE INSTRUMENT BROKE OFF. THE BROKEN PIECE WAS RETRIEVED. NO HARM TO PATIENT.