MAUDE Adverse Event Report: DEPUY MITEK MITEK OMNISPAN MENISCAL APPLIER

Catalog Number 228143

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2014

Event Type  Injury  

Event Description

Our sales rep reported that after successfully deploying the first implant of an omnispan meniscal repair system 12 degree needle, the second implant became stuck on the omnispan applier when the surgeon tried to deploy it.The sales rep reported the patient¿s tight joint space contributed to the surgeon over penetrating the meniscus.The surgeon completely removed this implant by pulling it out by the sutures and at this point performed a meniscectomy due to the lack of good tissue available to apply a second implant.The surgeon completed the procedure with no further harm to the patient.There was a 5 minute delay in the procedure.The customer already discarded the devices.See associated medwatch # 1221934-2014-00271.

Manufacturer Narrative

The complaint device was discarded at the facility and therefore not available for evaluation.The event reported indicates there could have been a potential issue with the omnispan applier and not the associated needle (medwatch # 1221934-2014-00271).However, without physically evaluating the devices, the exact failure or the root cause cannot be determined.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.The 12 month complaint rate for this failure was reviewed against the risk analysis document and found to be within the expected levels.Therefore, at this point in time, no further action is warranted.However, 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.

• Brand Name: MITEK OMNISPAN MENISCAL APPLIER
• Type of Device: MENISCAL APPLIER
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; quality department; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; na; raynham MA 02767
• Manufacturer Contact: siri belur ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 3910065
• MDR Text Key: 22141389
• Report Number: 1221934-2014-00270
• Device Sequence Number: 1
• Product Code: GEF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 228143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/05/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2014
• Date Manufacturer Received: 06/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1