MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. SYMMETRY SURGICAL; MAYO SCISSOR

Model Number	32-831
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received via voluntary medwatch report# mw5153838.Without additional details and/or return of the device, 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, "patient underwent repeat c-section.During surgical procedure the tip of a pair of straight mayo suture scissors broke off.The scissor tip was not retained in the patient and there was no harm to the patient.".
Additional Manufacturer Narrative
Received via voluntary medwatch report# mw5153838.The device was not able to be returned, however pictures were provided that confirmed the complaint.Additionally, the pictures confirmed that the lot number is 1606 which indicates that the device was manufactured in june 2016.Based on this information, it can be determined that the device had been in use for approximately 8 years prior to the damage occurring.Because the device was not returned, the material cannot be evaluated.Root cause: wear and tear.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, "patient underwent repeat c-section.During surgical procedure the tip of a pair of straight mayo suture scissors broke off.The scissor tip was not retained in the patient and there was no harm to the patient.".

• Brand Name: SYMMETRY SURGICAL
• Common Device Name: MAYO SCISSOR
• 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: 19393494
• Report Number: 3007208013-2024-00019
• Device Sequence Number: 6786366
• Product Code: LRW
• UDI-Device Identifier: 00887482071656
• UDI-Public: 00887482071656
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2024

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: 32-831
• Device Lot Number: 1606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown