MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY RAPIDCLEAN; KERRISON RONGUER

Catalog Number	58-3200J-BD
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned for evaluation.We have completed our initial evaluation of the device, however we are waiting for final paperwork on the device to complete the investigation.There has been a total of (b)(4) sold of all lots of this part number since 2012.There has been a total of 3 additional complaints recorded for similar occurrences.Two of which occurred in february and august of 2020 from the same customer.The one additional complaint was recorded in 2015 and was found to be the result of the hospital tampering with the screws.A final report will be submitted once we have all of the paperwork and information necessary.
Event or Problem Description
The screw came out of the kerrison during the procedure and fell into the patient.The screw was retrieved with no harm to the patient.

• Brand Name: SYMMETRY RAPIDCLEAN
• Common Device Name: KERRISON RONGUER
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 10775096
• Report Number: 3007208013-2020-00031
• Device Sequence Number: 14488729
• Product Code: HTX
• UDI-Device Identifier: 00887482102527
• UDI-Public: 00887482102527
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/02/2020

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 Catalogue Number: 58-3200J-BD
• Device Lot Number: T01-81802648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1