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

Model Number 90-5600

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Per medwatch report mw5152615, "during hysterectomy myoma screw being used to manipulate uterus broke off inside of uterus.".

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
• Type of Device: 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
• MDR Text Key: 341692455
• Report Number: 3007208013-2024-00015
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00887482130100
• UDI-Public: 00887482130100
• Combination Product (y/n): N
• PMA/PMN Number: K040855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• 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
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: No
• Patient Sequence Number: 1