MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY; RONGEUR

Catalog Number	58-3200-BD
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
The screw of the rongeur fell out during a procedure.
Additional Manufacturer Narrative
The customer did not provide any additional requested information regarding the patient involvement.Per the sales representative, the customer has refused any in-services since they began using this product earlier this year.Upon receiving the returned device, it was confirmed that the screw had fallen out.Upon further review of the device and the screw, it was noted that the screw head had damage that is consistent with the use of a tool.Per the general ifu, all parts that are meant to come apart, can be taken apart by hande.Parts requiring a tool should not be dismantled.Taking out the screw, breaks the weld point that was applied during manufacturing to hold the screw in place.There has been a total of 452 sold since 2012 with one additional complaint that was recorded in 2014.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 need for corrective actions a follow up report will be submitted.

• Brand Name: SYMMETRY
• Common Device Name: RONGEUR
• 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: 15116840
• Report Number: 3007208013-2022-00029
• Device Sequence Number: 17547612
• Product Code: HAE
• UDI-Device Identifier: 00887482102503
• UDI-Public: 00887482102503
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2022

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: 58-3200-BD
• Device Lot Number: T01-82105139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 07/27/2022
• 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