MAUDE Adverse Event Report: DEPUY MITEK LLC US ARTHRO GRASPER PEN 35 UP *EA; SUTURE/NEEDLE PASSER, REUSABLE

Catalog Number 214601

Device Problem Difficult to Open or Close (2921)

Patient Problem Not Applicable (3189)

Event Date 06/26/2019

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Investigation summary: the complaint device was received and inspected.The complaint can be confirmed.The device was received with the jaw already in the open position.When the trigger was pulled, the actuator bent upward out of the shaft of the device, and the jaw would not close.It appeared that the jaw had slipped out of the actuator.This type of failure can occur when the user attempts to grasp excessive amounts of suture with the jaw, therefore causing the actuator to dislocate from the jaw.However, given the information provided we cannot discern a definitive root cause for the reported failure.The potential cause for this issue is not related to manufacturing, therefore a manufacturing record evaluation is not required.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.This report is being filed as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.

Event Description

It was reported by the sales rep via phone that during sterilization it was noticed that when pressing the trigger on the customer's penetrating grasper 35 degree up the jaw did not open.Also, a spring like metal bar pops out when pressing the trigger.The sales rep stated that there was no case involved therefore no patient involvement or surgical delay to any case.The sales rep was not present for when the issue was found therefore could not provide any further information.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Type of Device: SUTURE/NEEDLE PASSER, REUSABLE
• 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 ; 6013142063
• MDR Report Key: 9128986
• MDR Text Key: 206781205
• Report Number: 1221934-2019-58645
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705003846
• UDI-Public: 10886705003846
• 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: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 214601
• Device Lot Number: 09G5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Initial Date Manufacturer Received: 06/26/2019
• Initial Date FDA Received: 09/27/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1