MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY KERRISON; RONGEUR

Catalog Number	57-0763-BD
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer was provided an rma to return the device for evaluation.We are still waiting for the device to complete our evaluation.There has been a total of 381 sold of all lots with no addiitional complaints recorded for this product code.A follow up report will be submitted once we have completed our evaluation.
Event or Problem Description
During a procedure, the screw fell out of the kerrison when it was being handed back to the mayo stand.The screw landed on the drape.There was no harm to the patient.
Additional Manufacturer Narrative
Lot# 22253/40 was returned on (b)(6) 2022 for evaluation.It was determined that this lot number was purchased in (b)(6) 2021.A review of the device and the returned screw, confirmed that there was damage on the screw head that is consistent with a tool being used to tamper with the screw.The screws on this device should never be removed except by an approved repair facility that will properly secure the screws.Removal of the screws by the facility is against the general reprocessing instructions for use.All devices that are meant to come apart will come apart by hand.If a tool is needed to take it apart, it should be left as is.There has been a total of 381 sold of this part number with no additional complaints recorded for this occurrence.Based on the above information this can be seen as the final report.If additional information is obtained that alleges additional patient involvement or information that is pertinent to the investigation, a follow up report will be submitted.

• Brand Name: SYMMETRY KERRISON
• 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: 15192496
• Report Number: 3007208013-2022-00031
• Device Sequence Number: 5902283
• Product Code: HAE
• UDI-Device Identifier: 00887482093337
• UDI-Public: 00887482093337
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

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: 57-0763-BD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 08/30/2022
• 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