MAUDE Adverse Event Report: DEPUY MITEK OMNISPAN MENISCAL REPAIR SYSTEM/27 DEGREE; MITEK MENISCAL IMPLANTS

Catalog Number 228142

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/28/2016

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.Although three separate events were reported in this complaint with 7 different devices, it has been determined that only one device is reportable as a malfunction.(b)(4).The lot expiration date is currently not available.Awaiting device return.

Event Description

(1 needle) the placing of the first meniscus seam was fine, when the second needle was loaded the silicone sleeve dissolved upon the peek 2.However, the silicone sleeve, thread, and peek residues could be removed under direct vision from the joint space.The placing of the first meniscus seam was fine, when the second needle was loaded the silicone sleeve was slashed, the second seam could not be placed.(1 needle): easy placement of the 1st and 2nd meniscus seam.However, the needle has bent during the procedure.Surgeon was visibly displeased with reference to the reliable products of direct competitors surgery was continued with same like product, all products that have been used were new products.

Manufacturer Narrative

The complaint devices were not received and is therefore unavailable for physical evaluation.The reported condition cannot be confirmed at this point.We will continue to remain receptive to additional information and update our records to reflect new findings.A batch record review has been conducted for each individual batch and the results indicate that these batches of product were 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 other complaints for these lots of devices that was released to distribution.At this point, no corrective action is required and 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Although three separate events were reported in this complaint with 7 different devices, it has been determined that only one device is reportable as a malfunction.(b)(4).

Manufacturer Narrative

The complaint needle was received attached to the omnispan gun.Visual observation of the returned needle reveals that the needle is bent at an angle beyond its intended design.This failure can be attributed to the user technique where excessive force was applied on the device causing it to bend.The root cause for the reported failure is application error/user technique.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.A dhr review has been conducted for each individual batch and the results indicate that these batches of product were 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 other complaints for these lots of devices that was released to distribution.

• Brand Name: OMNISPAN MENISCAL REPAIR SYSTEM/27 DEGREE
• Type of Device: MITEK MENISCAL IMPLANTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 5823730
• MDR Text Key: 50674641
• Report Number: 1221934-2016-10301
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150209
• 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,Followup,Followup
• Report Date: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 228142
• Device Lot Number: 3860692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 06/28/2016
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1