MAUDE Adverse Event Report: SYMMETRY SURGICAL LLC SYMMETRY RAPIDCLEAN; KERRISON RONGEUR

Catalog Number	58-4200J-BD
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product was being used for a trial and was from our library inventory.The product has not been returned yet for evaluation.There has been a total of (b)(4) sold of this product code with 3 complaints recorded for similar occurrences.In the 2 previous complaints, there were significant signs that the screw had been tampered with.A follow up report will be submitted one the part has been received and evaluated.
Event or Problem Description
During the use of the kerrison, the screw fell out.There was a delay in the procedure to search for the screw and retrieve it.
Additional Manufacturer Narrative
Upon evalauting the returned device, it was noted that the screw was not returned with the kerrison.Without the screw it is difficult to tell if there was any damage to the screw as a result of screw removal at some point.However, there were weld marks where the back of the screw would be that indicates that the screws were properly welded into place.As a result of the evaluation, a true root cause could not be determined.This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or need for corrective actions, a follow up report will be submitted.

• Brand Name: SYMMETRY RAPIDCLEAN
• Common Device Name: KERRISON RONGEUR
• Manufacturer (Section D): SYMMETRY SURGICAL LLC; 3034 owen drive; antioch, tn
• MDR Report Key: 10512197
• Report Number: 3007208013-2020-00023
• Device Sequence Number: 16787098
• Product Code: HTX
• UDI-Device Identifier: 00887482102701
• UDI-Public: 00887482102701
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2020

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: 58-4200J-BD
• Device Lot Number: BJ0814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1