MAUDE Adverse Event Report: SMITH NEPHEW, INC. FIRSTPASS; PASSER

Model Number 22-4038

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 01/03/2022

Event Type  malfunction  

Event Description

Small piece of metal broke off inside patient's shoulder from firstpass suture passer, retrieved by attending physician.

• Brand Name: FIRSTPASS
• Type of Device: PASSER
• Manufacturer (Section D): SMITH NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 13384636
• MDR Text Key: 284623611
• Report Number: 13384636
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22-4038
• Device Catalogue Number: 22-4038
• Device Lot Number: 2080241
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/19/2022
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 01/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Race: White