FDA.reportPublic FDA data

MAUDE MDR 8275274

MDR report key
8275274
Report number
1221934-2019-56109
Event key
0
Event type
3
Date of event
2017-05-03
Date received
2019-01-24
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 USGEF228143L179388R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-240

Event Narratives#

N

Patient 1

IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4). THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE IS UNAVAILABLE FOR A PHYSICAL EVALUATION. 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 WITH AN UNRELATED OT-281881 THAT WAS OPENED RELATING TO REPAIR OF THE LIGHT SOURCE ON THE ERGONOMIC PRESS, STATED WITH NO LINK TO THE REPORTED INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY KIND FOR THIS LOT OF (B)(4) DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED FAILURE MODE. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. 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. 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 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER'S OMNI SPAN MENISCAL DEPLOYMENT GUN AND TWO OMNI SPAN MENISCAL REPAIR, 12-DEGREE NEEDLES WERE DEPLOYING BOTH IMPLANTS AT THE SAME TIME DURING A MENISCAL REPAIR SURGICAL PROCEDURE. ACCORDING TO THE REPORTER, THE IMPLANTS WERE PULLED OUT WITHOUT CUTTING INTO THE MENISCUS. THE CASE WAS COMPLETED BY SWITCHING TO OTHER LIKE DEVICES. THERE WERE NO PATIENT CONSEQUENCES BUT A 5-MINUTE DELAY WAS REPORTED. THE DEVICES WERE DISCARDED BY THE CUSTOMER. THE SALES REP WAS NOT PRESENT FOR THE CASE AND COULD NOT PROVIDE ANY MORE DETAILS. 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.