MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY GIGLI; SAW WIRE

Model Number	75-1003
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information was not available.The device was discarded immediately after use, therefore pictures could not be provided and the device could not be returned for evaluation.A review of the customer's order history determined that the most recent purchase for this product code was 2014.This indicates that the device used was at least 7 years old.However, this cannot be confirmed as the customer was not able to provide a lot number.Based on the information available, a true root cause cannot be determined.However, it is likely that the device had significant wear and tear over 7 years of use.There has been a total of 908 sold since 2012 with no additional complaints recorded.This is an isolated event and no further actions are required.We will continue to track and trend for future occurrences.This can be seen as the final report.If additional information is obtained that alleges additional patient involvement or the need for corrective actions, a follow up report will be submitted.User facility report# 2200101000-2021-8019.This submission is passed due as we recently discovered that the original submission was not accepted due to an old version of esubmitter.
Event or Problem Description
The customer alleged that the gigli saw cables broke during use.No pieces were broken off in the body.

• Brand Name: SYMMETRY GIGLI
• Common Device Name: SAW WIRE
• 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: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 13544452
• Report Number: 3007208013-2021-00034
• Device Sequence Number: 5721347
• Product Code: GFA
• UDI-Device Identifier: 00887482030097
• UDI-Public: 00887482030097
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/02/2021

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: 75-1003
• Device Catalogue Number: 75-1003
• Device Lot Number: UNKNOWN
• 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: 11/18/2021
• Initial Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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