PERIOSTEAL ELEVATOR 3MM CURVED BLADE-STRAIGHT EDGE
Received Nov 14, 2017 · Event occurred Oct 21, 2017
Report 9680938-2017-10141 · MDR key 7030658
Device
Product problems
- Break
- Break
Patient
47 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
PATIENT¿S WEIGHT IS UNKNOWN. (B)(4). LOT NUMBER UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem
IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A PILON FRACTURE PERFORMED ON (B)(6) 2017, TWO PERIOSTEAL ELEVATORS BROKE IN HALF DURING REDUCTION OF FRACTURE FRAGMENTS. THE EVENT DID NO EFFECT THE OUTCOME OF THE CASE OR CAUSE ANY SIGNIFICANT DELAY. THE TIME OF DELAY IN UNKNOWN AND PATIENT¿S OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) PERIOSTEAL ELEVATOR 3MM CURVED BLADE-STRAIGHT EDGE THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).