MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. SYMMETRY SURGICAL; MYOMA SCREW

Model Number	90-5600
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Per medwatch report mw5152615, "during hysterectomy myoma screw being used to manipulate uterus broke off inside of uterus.".
Additional Manufacturer Narrative
The information was received through fda's medwatch program (report number mw5152615).There is no user facility information provided and no device available to obtain.As such, a true root cause could not be established.Based on the above information, no further actions are required and this can be seen as the final report.If additional information is obtained that is pertinent to the investigation, a follow-up report will be submitted.

• Brand Name: SYMMETRY SURGICAL
• Common Device Name: MYOMA SCREW
• Manufacturer (Section D): SYMMETRY SURGICAL INC.; 3034 owen drive; antioch TN
• 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: 19177492
• Report Number: 3007208013-2024-00015
• Device Sequence Number: 7430947
• Product Code: GEI
• UDI-Device Identifier: 00887482130100
• UDI-Public: 00887482130100
• Combination Product (Y/N): N
• PMA/510(K) Number: K040855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2024

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: 90-5600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown