MAUDE Adverse Event Report: SYMMETRY SURGICAL SYMMETRY; KERRISON RONGEUR

Model Number	57-0763
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer states that the device is not available to return.The customer was not able to provide pictures, the lot number, or provide purchase information to determine the lot number.Without this important information, a true root cause cannot be determined.There has been a total of (b)(4) sold of all lots with one additional complaint recorded for a similar occurrence.Based on the above information, no further actions are required and the complaint can be closed.This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or additional information that is pertinent to the investigation, a follow up report will be submitted.
Event or Problem Description
The customer alleged that the rongeur broke while in use.The pin that holds the instrument together, came out which prevented use.There was no harm to the patient.

• Brand Name: SYMMETRY
• Common Device Name: KERRISON RONGEUR
• Manufacturer (Section D): SYMMETRY SURGICAL; 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: 15801878
• Report Number: 3007208013-2022-00046
• Device Sequence Number: 7027712
• Product Code: HAE
• UDI-Device Identifier: 00887482093313
• UDI-Public: 00887482093313
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/15/2022

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 Model Number: 57-0763
• Device Catalogue Number: 57-0763
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 11/15/2022
• 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