MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC.; REUSABLE NEEDLE HOLDER

Device Problem Component Missing (2306)

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

Event Date 02/19/2020

Event Type  malfunction  

Event Description

While the medical student was closing subcutaneous tissue with a suture the needle holder would not work properly.Upon observation of the needle holder a piece of metal from the one side of the jaw of the needle holder was missing.

• Type of Device: REUSABLE NEEDLE HOLDER
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9915489
• MDR Text Key: 186124024
• Report Number: 9915489
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/02/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 9855 DA