MAUDE Adverse Event Report: CODMAN/SYMMETRY SURGICAL GMBH CLASSIC PLUS NEEDLE DRIVER; HOLDER, NEEDLE; ORTHOPEDIC

Patient Problem Foreign Body In Patient (2687)

Event Date 12/04/2023

Event Type  Injury  

Event Description

Needle driver broke while in use, all pieces retrieved.

• Brand Name: CLASSIC PLUS NEEDLE DRIVER
• Type of Device: HOLDER, NEEDLE; ORTHOPEDIC
• Manufacturer (Section D): CODMAN/SYMMETRY SURGICAL GMBH
• MDR Report Key: 18282770
• MDR Text Key: 330044847
• Report Number: MW5148935
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 87 KG