MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY SURGICAL INC; NEEDLE HOLDER

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 12/04/2023

Event Type  malfunction  

Manufacturer Narrative

Symmetry surgical was made aware of this complaint via a voluntary medwatch report from the fda.Mw# mw5148935.The report did not provide a product code or lot number.We are attempting to gather additional information from the user facility for complaint investigation.If additional information is obtained or information that is pertinent to the investigation, a supplemental report will be submitted.

Event Description

The customer alleged that a needle driver broke while in use.All pieces were retrieved.The complaint was received via voluntary medwatch report# mw5148935.No further information has been provided at this time.

• Brand Name: SYMMETRY SURGICAL INC
• Type of Device: NEEDLE HOLDER
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• Manufacturer (Section G): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013
• MDR Report Key: 18543051
• MDR Text Key: 333487636
• Report Number: 3007208013-2024-00001
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/19/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2023
• Initial Date FDA Received: 01/19/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1