MAUDE Adverse Event Report: DEPUY MITEK, LLC IDEAL; INSTRUMENT, LIGATURE PASSING AND KNOT TYING

Model Number 251004

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 10/23/2017

Event Type  malfunction  

Event Description

Tip of mitek suture shuttle broke off into wound during use.Tip removed and item taken out of service to return to company.

• Brand Name: IDEAL
• Type of Device: INSTRUMENT, LIGATURE PASSING AND KNOT TYING
• Manufacturer (Section D): DEPUY MITEK, LLC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7048277
• MDR Text Key: 92635435
• Report Number: 7048277
• Device Sequence Number: 0
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2021
• Device Model Number: 251004
• Device Catalogue Number: 251004
• Device Lot Number: 16P27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/01/2007
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/03/2017
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 11/03/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR