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

Model Number	36-3011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received via medwatch report# mw5154902.The information was received through the fda with no customer information provided.As such, no investigation can be completed, confirmation of the complaint is undeterminable, and a true root cause can not be established.If additional information is obtained that is pertinent to the investigation or provides additional details a follow-up report will be provided.Until such time, this can be seen as the final report.
Event or Problem Description
The complainant alleges, "during needle driver inspection to assess for instrument integrity prior to use, the needle driver tip was detected to be bent with a small portion of it that broke off.The needle driver was never utilized during the case and it along with the broke tip were subsequently sequestered.".

• Brand Name: SYMMETRY SURGICAL INC.
• Common Device Name: 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: steven fox ; 3034 owen drive; antioch, TN 37013
• MDR Report Key: 19632995
• Report Number: 3007208013-2024-00031
• Device Sequence Number: 12960255
• Product Code: HXK
• UDI-Device Identifier: 00887482009888
• UDI-Public: 00887482009888
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/28/2024

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 Model Number: 36-3011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown