FDA.reportPublic FDA data

MAUDE MDR 8318151

MDR report key
8318151
Report number
1017294-2019-00008
Event key
0
Event type
3
Date of event
2018-12-27
Date received
2019-02-07
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
MELANIE HANSEN
Address
11311 CONCEPT BOULEVARD LARGO FL 33773 US
Phone
727-727-7273
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
14.5MM-15MM LIBERATOR KNIFEKNIFE, ORTHOPEDICCONMED CORPORATIONHTS25.5001425.5001445993Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-02-070

Event Narratives#

N

Patient 1

EXAMINATION CONFIRMED THE REPORTED PROBLEM AND FOUND THE TIP BROKEN OFF. THE BROKEN TIP WAS RETURNED FOR EVALUATION AND IS APPROXIMATELY 0.335 INCHES. BROKEN TIP WAS DAMAGED AT THE CUTTING EDGES. EXAMINATION COULD NOT FIND ANY ISSUES WITH CRITICAL DIMENSIONS. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WERE FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN 2 COMPLAINTS REGARDING 2 DEVICES FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THE SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED, THE RATE OF FAILURE WOULD BE (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING; INSPECT INSTRUMENTS AFTER USE TO ENSURE IT HAS NOT BEEN DAMAGED. DO NOT USE EXCESSIVE FORCE ON INSTRUMENTS TO AVOID DAMAGE OR BREAKAGE DURING USE. AVOID UNINTENDED CONTACT WITH OTHER SURGICAL INSTRUMENTS DURING USE TO PREVENT DAMAGE OR BREAKAGE. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

D

Patient 1

THE CUSTOMER REPORTED THAT THE 25.50014, 4.5MM LIBERATOR KNIFE BROKE DURING A SLAP REPAIR ON (B)(6) 2018. IT'S REPORTED THE " TIP PART WAS BROKEN AFTER THE SURGEON WAS ISOLATING LABRUM FROM HUMERAL HEAD. THE BROKEN PIECE FELL INSIDE OF A PATIENT'S BODY, BUT IT WAS REMOVED USING GRASPER. SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT AN ALTERNATE DEVICE." THERE WAS NO REPORTED PATIENT INJURY AND A 1-MINUTE REPORTED DELAY OF SURGERY. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.