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 02/25/2019

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.A visual inspection was performed to reveal any gross visual defects that may contribute to the complaint condition.It was observed that the actuator was free from the handle assembly at the proximal end.A functionality check of the device confirmed that the actuator could not open or close the upper jaw of the device as the trigger assembly was pushed or pulled.This type of failure is typically observed when the user grasps excessive amounts of suture in the jaw of the device, therefore placing excessive stress on the actuator assembly.When this occurs, the shear pin can break at the proximal end which holds the actuator to the trigger therefore is a potential root cause for the reported failure.However, given the information provided we cannot discern a definitive root cause for the reported failure.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 affiliate in (b)(6) that during shoulder repair arthroscopy, it was observed that the opening / closing mechanism on the arthro grasper pen 35 up *ea device was not working.The procedure was completed with a second device with no patient harm, but with a five to ten minute delay.There was a delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was 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: 9128570
• MDR Text Key: 161807391
• Report Number: 1221934-2019-58638
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705003846
• UDI-Public: 10886705003846
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/26/2019

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: 17B01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2019
• 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