FDA.reportPublic FDA data

MAUDE MDR 6630182

MDR report key
6630182
Report number
2520274-2017-11785
Event key
0
Event type
3
Date received
2017-06-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MICHAEL COTE
Address
1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US
Phone
610-610-6107
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PASSER, WIRE, ORTHOPAEDICSYNTHES USAHXIY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-06-090

Event Narratives#

N

Patient 1

THERE WAS NO KNOWN REPORTED PATIENT INVOLVEMENT ASSOCIATED WITH THE COMPLAINED EVENT. UNKNOWN WHEN DEVICE MALFUNCTIONED. (510K): THIS REPORT IS FOR ONE (1) UNKNOWN K-WIRE. PART AND LOT NUMBERS ARE UNKNOWN. WITHOUT THE SPECIFIC PART AND LOT NUMBER, THE UDI IS NOT AVAILABLE. DEVICE IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. A PRODUCT INVESTIGATION WAS PERFORMED. THIS COMPLAINT IS CONFIRMED. THE RETURNED INSERTION GUIDE IS MISSING THE SET SCREW COMPONENT AND A BROKEN PIECE OF AN UNKNOWN K-WIRE IS STUCK INSIDE THE PROXIMAL HOLE OF THE INSERTION GUIDE. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION AS THE RETURNED INSERTION GUIDE IS MISSING A COMPONENT AND THE K-WIRE IS ALREADY BROKEN. IT CANNOT BE DEFINITIVELY DETERMINED THAT THE UNKNOWN PORTION OF BROKEN K-WIRE IS A SYNTHES DEVICE. HOWEVER, ON (B)(6) 2017 DURING THE INVESTIGATION OF THE RETURNED DEVICE, IT WAS DETERMINED THAT IT MOST LIKELY IS A SYNTHES K-WIRE BASED ON THE FACT THAT SYNTHES K-WIRES ARE AVAILABLE IN THE 3.5MM LCP PROXIMAL HUMERUS PLATES SET THAT HOUSES THIS INSERTION GUIDE. NO NEW MALFUNCTIONS WERE IDENTIFIED AS A RESULT OF THE INVESTIGATION. A VISUAL INSPECTION UNDER 5X MAGNIFICATION, DEVICE HISTORY RECORD (DHR) REVIEW AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. A SMALL PORTION OF THE BROKEN K-WIRE IS PROTRUDING FROM THE INFERIOR SIDE OF THE PLATE HOLE. THE K-WIRE IS VERY DEFORMED (POST MANUFACTURING DAMAGE) AND AN ACCURATE MEASUREMENT OF THE DIAMETER OF THE K-WIRE WAS UNABLE TO BE OBTAINED AT CQ. THE SET SCREW COMPONENT IS MISSING FROM THE INSERTION GUIDE. A REVIEW OF THE DEVICE HISTORY RECORDS WAS UNABLE TO BE PERFORMED SINCE THE LOT NUMBER WAS UNKNOWN. A DRAWING REVIEW WAS UNABLE TO BE PERFORMED SINCE THE UNKNOWN K-WIRE PART # WAS UNKNOWN. UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. MOST LIKELY DUE TO REMOVING SET SCREW FOR STERILE PROCESSING AND MISPLACING IT AND FORCING A PREVIOUSLY MALFORMED/DAMAGED K-WIRE IN THE INSERTION GUIDE HOLE LEADING TO K-WIRE BREAKAGE AND DEFORMATION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. 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.

D

Patient 1

IT WAS REPORTED THAT AN INSERTION GUIDE IS MISSING ONE SET SCREW AND AN UNKNOWN BROKEN K-WIRE IS STUCK IN THE HOLE OF THE INSERTION GUIDE. THE ISSUES WERE FOUND AFTER STERILE PROCESSING. THERE WERE NO REPORTED ISSUES WITH THE INSERTION GUIDE PRIOR TO THIS DISCOVERY. IT IS UNKNOWN IF THERE IS A CASE OR PATIENT INVOLVEMENT HOWEVER, NO REPORTED ISSUES DURING THE CASE THE DEVICE WAS LAST USED IN. IT IS UNKNOWN HOW LONG THE INSERTION GUIDE HAS BEEN IN USE. THIS REPORT IS FOR ONE (1) UNKNOWN K-WIRE. THIS IS REPORT 1 OF 1 FOR COMPLAINT COM-(B)(4).