MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY; KAYE SCISSORS

Model Number	32-698
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received and an initial evalaution has been completed.The device was returned to the contract manufacturing facility for further evaluation.There has been a total of 67 sold of all lots with no additional complaints recorded.A follow up report will be submitted once the manufacturing facility has completed their evaluation.
Event or Problem Description
The customer alleged that during a plastic surgery case, the piece of broken tip fell inside of the patient.The piece was recovered without issues.
Additional Manufacturer Narrative
Symmetry's supplier sent the device the manufacturing facility in germany for evalaution.The material of the device was confirmed to be within conformance.The damage noted was the result of excessive stress on the device.This is an isolated event.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 alleges any additional patient involvement or additional informaiton pertinent to the investigation, a subsequent follow up report will be submitted.

• Brand Name: SYMMETRY
• Common Device Name: KAYE SCISSORS
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• Manufacturer (Section G): SYMMETRY SURGICAL; 3034 owen drive; antioch TN 37013
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 17148575
• Report Number: 3007208013-2023-00026
• Device Sequence Number: 5421510
• Product Code: LRW
• UDI-Device Identifier: 00887482071298
• UDI-Public: 00887482071298
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2023

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
• Operator of Device: Health Professional
• Device Model Number: 32-698
• Device Catalogue Number: 32-698
• Device Lot Number: 030419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown