FDA.reportPublic FDA data

MAUDE MDR 7837417

MDR report key
7837417
Report number
1221934-2018-54165
Event key
0
Event type
3
Date of event
2014-07-23
Date received
2018-08-31
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
MRS. JENNIFER LAWRENCE
Address
325 PARAMOUNT DRIVE RAYNHAM MA 02767 US
Phone
508-508-5088
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OMNISPAN MENISCAL APPLIERORTHOPAEDIC CERCLAGE APPLIERDEPUY MITEK LLC USGEF2281433620306Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-310

Event Narratives#

N

Patient 1

IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. EVALUATION STATEMENT: THIS FAILURE MODE WAS INVESTIGATED UPON RECEIVING THE RETURNED APPLIER AND NEEDLE. UPON RECEIPT OF THE DEVICE, THE NEEDLE WAS ON THE APPLIER WITH THE SLIDING IMPLANT. BOTH TRIGGERS WERE TESTED FOR FUNCTIONALITY. THE APPLIER WAS UNABLE TO ADVANCE (RED TRIGGER) OR DEPLOY (GRAY TRIGGER) THE SLIDING IMPLANT AS WAS NOTED IN THE COMPLAINT, THUS CONFIRMING THE FAILURE MODE. THE GRAY TRIGGER WAS NOT UNDER TENSION FROM THE INTERNAL SPRING AS WOULD BE TYPICAL WITH THE MAIN PUSHER ROD JAMMED UNDER THE SLIDING IMPLANT. THE SLIDING IMPLANT WAS UNABLE TO BE MOVED UTILIZING THE GRAY OR RED TRIGGERS, THUS AGAIN CONFIRMING THE JAMMING CONDITION. IT WAS ALSO NOTED THE SLIDING IMPLANT HAD MOVED FROM ITS ORIGINAL POSITION AND WAS LOCATED ON THE RAMP, WHICH IS TYPICAL OF A MOVEMENT DUE TO INTERACTION WITH SURROUNDING STRUCTURES AROUND THE AREA OF REPAIR. WHILE PULLING OUT OF THE MENISCUS TO PREPARE FOR THE 2ND DEPLOYMENT, THE MENISCUS OR A SURROUNDING STRUCTURE CAUSED THE SLIDING IMPLANT TO MOVE DOWN THE RAMP. THESE CONDITIONS COULD LEAD TO THE IMPLANT AND PUSHER ROD OCCUPYING THE SAME SPACE, THUS CAUSING THE JAMMING CONDITION. THEREFORE, THE JAMMING CONDITION CAN BE ATTRIBUTED TO USE ERROR IN THESE CONDITIONS IN THE MENISCUS. A BATCH RECORD REVIEW HAS BEEN CONDUCTED AND 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 MITEK COMPLAINTS SYSTEM REVEALED NO SIMILAR COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY 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. UDI: (B)(4). THIS REPORT IS BEING FILED FROM THE (B)(4) 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 AFFILIATE IN (B)(6) THAT DURING MENISCAL REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE OMNISPAN MENISCAL APPLIER DEVICE DID NOT WORK ON THE OMNISPAN MENISCAL REPAIR SYSTEM, W/ 12 DEGREE NEEDLE, EA WHILE IN USE TOGETHER. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. 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.