MAUDE Adverse Event Report: DEPUY MITEK OMNISPAN MENISCAL APPLIER; ORTHOPAEDIC CERCLAGE APPLIER

Catalog Number 228143

Device Problems Positioning Failure (1158); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2015

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The complaint device was received and inspected visually and functionally.Visual observation reveals no anomalies on the device.When tested for its functionality, both triggers functioned properly when pulled on their own without a needle attached to the device.A 0 degree needle was loaded onto the applier and both implants were deployed successfully.The applier works as intended and we cannot confirm the reported complaint.No additional information provided as to what the exact failure experience by the user was.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 depuy synthes mitek complaints system revealed no other complaints of any type for this lotreleased to distribution.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.(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.

Event Description

This is report 1 of 3 for the same event.It was reported by the affiliate in (b)(6) that during an anterior cruciate ligament (acl) surgical procedure, after assessing and preparing the meniscus repair site, omnispan was assembled and first stitch was attempted.In the first stitch, the first back stop misfired in the sense that it did not go through the meniscus completely.A misfire was discovered at the time of trying to tighten the knot after deploying the second back stop.Surgeon had to cut the suture and remove the stitch.After this, the surgeon attempted to take a second stitch with fresh needle and this time the first back stop caught the meniscal rim properly.However, when trying to advance the second back stop with red trigger, the movement was not appropriate even after three tries and after that the trigger just jammed up (red trigger as well as grey trigger).Hence the second back stop could not be deployed.Again the surgeon had to cut the suture to free the instrument from the joint.It was reported that a competitor¿s implant was deployed very close to the locations - approximately 2-3 mm apart.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.

• Brand Name: OMNISPAN MENISCAL APPLIER
• Type of Device: ORTHOPAEDIC CERCLAGE APPLIER
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7796580
• MDR Text Key: 117573152
• Report Number: 1221934-2018-54075
• Device Sequence Number: 1
• Product Code: GEF
• UDI-Device Identifier: 10886705010059
• UDI-Public: 10886705010059
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 228143
• Device Lot Number: 3826022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2015
• Date Manufacturer Received: 09/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ANCHOR DEVICES