MAUDE Adverse Event Report: DEPUY MITEK LLC US MENISCAL DEPLOYMENT GUN; ORTHOPAEDIC CERCLAGE APPLIER

Catalog Number 228143

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Not Applicable (3189)

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint omnispan applier was received and evaluated.The inspection of the applier revealed that the deployment rod was jammed in the needle, causing the gray trigger to be inoperable.After removing the needle from the applier it was found that the deployment rod (gray trigger) and loading rod (red trigger) were in the opposite positions of the correct configuration (loading rod on top, deployment rod on bottom).The applier was assembled incorrectly, with the loading rod being placed on bottom and the deployment rod on top.Because of the incorrect assembly of the device, when the surgeon attempted to deploy the first implant, the deployment rod deployed both the first and second implants simultaneously.To confirm this a meniscus simulator was used to test the applier with a new needle.Depressing the gray trigger deployed both the first and second implants with a single trigger pull.The failure of the applier can be attributed to incorrect assembly of the device.No lot numbers were supplied which precludes conducting a device history record review or a lot specific search in the complaints handling system.The omnispan applier is being returned to the supplier for further investigation.A nonconformance was opened to investigate this failure (nc # (b)(4)).At this point in time, no immediate 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.This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.(b)(4).The lot number is unknown.

Event Description

It was reported by the affiliate that at the time of surgery using ominispan meniscal repair 0 °, the applicator did not fire the second stitch.To solve the problem was necessary to open new suture, when changing the load, same problem occurred, continued not firing the second point.Considering that the doctor which has enough experience with handling the product requested authorization to send the product for analysis.There was no harm to the patient and the surgery did not exceed time longer than 30 minutes.Images below.Additional information received via email from the affiliate on 2-27-2017 the first implant was left implanted, no problem related to the first fire.It was necessary to open a new suture to complete the procedure.Additional information received via email from the affiliate on 3-22-2017 reporting same location was used to complete the procedure.It was also reported that the device and needles will be returned for evaluation.

• Brand Name: MENISCAL DEPLOYMENT GUN
• Type of Device: ORTHOPAEDIC CERCLAGE APPLIER
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 8352174
• MDR Text Key: 136607007
• Report Number: 1221934-2019-56437
• Device Sequence Number: 1
• Product Code: GEF
• UDI-Device Identifier: 10886705010059
• UDI-Public: 10886705010059
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 228143
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2017
• Date Manufacturer Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1