FDA.reportPublic FDA data

MAUDE MDR 8261923

MDR report key
8261923
Report number
1221934-2019-56048
Event key
0
Event type
3
Date of event
2016-07-25
Date received
2019-01-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
KARA DITTY-BOVARD
Address
325 PARAMOUNT DRIVE RAYNHAM MA 02767 US
Phone
601-601-6013
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MENISCAL DEPLOYMENT GUNORTHOPAEDIC CERCLAGE APPLIERDEPUY MITEK LLC USGEF2281433906348* R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-180

Event Narratives#

N

Patient 1

IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4). THE EXP DATE IS CURRENTLY UNAVAILABLE. THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATION OF THE DEVICE REVEALS THE TIP OF THE PUSHER ROD WAS BENT UPWARDS AND THE DISTAL PART OF THE ROD WAS BENT SIGNIFICANTLY DOWNWARDS. THIS IS POSSIBLY DUE TO FORCED LOADING/UNLOADING OF THE NEEDLE. THERE WAS NO DAMAGE TO THE LOADING ROD. THE PUSHER AND LOADING RODS WERE COVERED WITH STAINS; INDICATING THAT THEY WERE USED. THE DAMAGE TO TIP OF THE MAIN PUSHER ROD COULD POTENTIALLY CAUSE THE SECOND IMPLANT TO DEPLOY BEFORE THE FIRST IMPLANT AND CAUSE MISFIRING. OTHER THAN THIS POSSIBILITY, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS POINT FROM THE DETAILS PROVIDED. THE NEEDLE ASSOCIATED WITH THIS INCIDENT WAS NOT AVAILABLE AT THE TIME OF INVESTIGATION. A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED DISSIMILAR COMPLAINT FOR THIS LOT RELEASED TO DISTRIBUTION. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PRODUCT CODE 228143, LOT 3906348 COMBINATION AND NO NON-CONFORMANCES WERE IDENTIFIED. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. IF ANY ADDITIONAL INFORMATION IS OBTAINED, THIS COMPLAINT WILL BE RE-OPENED TO CAPTURE THAT INFORMATION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. THIS REPORT IS BEING FILED FROM THE ETQ COMPLAINT MANAGEMENT SYSTEM AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS.

D

Patient 1

THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION ACL/MENISCUS REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SECOND ANCHOR WOULD START TO DEPLOY WHEN USING THE CUSTOMER'S OMINSPAN MENISCAL REPAIR 12 DEGREE AND THE CUSTOMER'S MENISCAL DEPLOYMENT GUN BEFORE THE FIRST IMPLANT WOULD DEPLOY. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH OTHER LIKES DEVICES WITH NO PATIENT CONSEQUENCES BUT THERE WAS A FIVE MINUTE DELAY. THE SALES REP STATED THAT THEY ARE UNSURE IF THE GUN IS AT FAULT OR THE IMPLANTS. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.