MAUDE Adverse Event Report: DEPUY MITEK LLC US IDEAL SUTGRASPER 60 DEG *EA; SUTURE/NEEDLE PASSER, REUSABLE

Model Number 251723

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2020

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).The lot number was unknown.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported by the affiliate in (b)(6) that during ric (radial incision and cutting) surgery on (b)(6) 2020, it was observed that the soft tissue got stuck in the wire of the suture grasper and the tip was broken.The procedure was completed with the broken piece left in the patient and was delayed for 30 minutes without any harm to the patient.There was no additional intervention planned for the patient.The surgeon reviewed the issue and confirmed that the event was triggered by the surgical technique.The device was the first use when the issue occurred.No additional information could be provided.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary :the complaint device is unavailable for a physical evaluation as some parts of the device are left in the patient and our affiliate informed us that the remaining parts are not going to be returned.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Further, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.At this point in time, 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.

• Type of Device: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10339475
• MDR Text Key: 200838215
• Report Number: 1221934-2020-01951
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705012312
• UDI-Public: 10886705012312
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 251723
• Device Catalogue Number: 251723
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention