STERNUM BLADE
Received Jul 26, 2017 · Event occurred Jun 30, 2017
Report 0001811755-2017-01404 · MDR key 6745000
Device
Generic name
Blade, Saw, Surgical, Cardiovascular
Manufacturer
Stryker Instruments-kalamazooCatalog number
0298097100
Lot number
UNKNOWN
Product problems
- Break
- Break
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE.
Description of Event or Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE BLADE WAS BROKEN INSIDE THE PACK. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
THE UNUSED BLADE IN THE POLYBAG WAS RETURNED FOR EVALUATION. INVESTIGATION RESULTS INDICATE THAT FROM THE DAMAGE TO THE BLADE AND THE POLYBAG IS LIKELY CAUSED BY AN EXCESSIVELY LARGE COMPRESSION FORCE. THIS DAMAGE IS CONSIDERED EXCESSIVE AND NOT EXPECTED DURING NORMAL STORAGE AND DISTRIBUTION OF THESE PRODUCTS. THE IFU OF HANDPIECES ASSOCIATED WITH THIS DEVICE WARN THE USER TO INSPECT THE PRODUCT BEFORE USE: "UPON INITIAL RECEIPT AND BEFORE EACH USE, OPERATE THE EQUIPMENT AND INSPECT EACH COMPONENT FOR DAMAGE. DO NOT USE ANY COMPONENT IF DAMAGE IS APPARENT." THE INVESTIGATION IS COMPLETE.
Description of Event or Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE BLADE WAS BROKEN INSIDE THE PACK. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.