MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY KARLIN; RETRACTOR BLADE

Model Number	46-3204
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receiving the returned device, it was confirmed that the blade had broken into two pieces.A true root cause of how the damage occured is unknown.However, we can assume that a small crack had to form in the material at some point prior to use.The device had been in use for approximately two years before the incident occurred.The material and hardness of the device were checked with all reading found to be within conformance per the product specifications and intended use.This is the first occurrence that we have received for this occurrence.Therefore this is an isolated event.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 allages any additional patient involvement or need for corrective actions, a follow up report will be submitted.
Event or Problem Description
The retractor had been in place for approximately 20 minutes in the patient while the surgeon was working without incident.The surgical staff was preparing to drape the patient and bringin o-arm for imaging, when the retractor blade suddlenly broke into two pieces.When the blade broke it ejected itself out of the patient onto the floor.The patient was checked for fragments from the break with nothing found inside the patient.There was no further impact on the patient.

• Brand Name: SYMMETRY KARLIN
• Common Device Name: RETRACTOR BLADE
• 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: 14220136
• Report Number: 3007208013-2022-00010
• Device Sequence Number: 5779542
• Product Code: GZT
• UDI-Device Identifier: 00887482015070
• UDI-Public: 00887482015070
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K882071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/27/2022

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 Model Number: 46-3204
• Device Catalogue Number: 46-3204
• Device Lot Number: R002S283/98
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 04/27/2022
• 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