MAUDE Adverse Event Report: SMITH AND NEPHEW SMITH AND NEPHEW FIRST PASS AUTO SUTURE DEVICE; FIRST PASS - ARTHROCARE

Model Number 5.5 MM

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

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 08/28/2017

Event Type  Injury  

Event Description

Patients initial surgery was on (b)(6) 2017.On (b)(6) 2017 patient had left shoulder arthroscopic synovectomy and removal of retained foreign body in left shoulder.Small metallic piece identified as upper catching jaw of the autosuture firstpass.

• Brand Name: SMITH AND NEPHEW FIRST PASS AUTO SUTURE DEVICE
• Type of Device: FIRST PASS - ARTHROCARE
• Manufacturer (Section D): SMITH AND NEPHEW
• MDR Report Key: 6912180
• MDR Text Key: 88164593
• Report Number: 6912180
• Device Sequence Number: 1
• 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: Other
• Type of Report: Initial
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5.5 MM
• Device Catalogue Number: 22-4036
• Device Lot Number: 50624822
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/31/2017
• Distributor Facility Aware Date: 08/28/2017
• Event Location: Ambulatory Surgical Facility
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 40 YR
• Patient Weight: 133