MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY CLASSIC PLUS; NEEDLE HOLDER

Model Number	36-3010
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receiving the returned device, it was confirmed that the manufacturing date code on the device was 104 which indicates that the device was manufactured in april 2010.It was confirmed that approximately 3/4 of the tungsten carbide insert broke away from the device.A further evaluation noted that the tip of the needle hold jaws was bent outward which is indicative of extreme stress on the needle holder jaws.There has been a total of 8,195 sold of all lots since 2012 with no additional complaints recorded.In conclusion, based on our review of the returned device, the damage occurred due to extreme force on the inserts with the addition of extended use over approximately 13 years.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 additional information pertinent to the investigation, a follow up report will be submitted.
Event or Problem Description
The customer alleged that the patient was undergoing a bifrontal craniotomy.At the time if closure, a classic plus needle holder was being used to place sutures for dural closure.During the placement of the suture a portion of the jaw plate broke away from the needle holder and the fractured portion of the jaw plate unknowingly fell into the surgical bed.This was not noticed by the surgical team, nor the or staff intraoperatively, and closing continued.The procedure was finished without issues.Post procedure, the patient underwent routine postoperative head ct where a metallic object was identified within the surgical bed.The surgical team determined this was not an intentionally placed surgical item.It was decided by the surgical team to take the patient back to the or the next day to retrieve the unknown retained item.Once the surgical wound was reopened, they identified the object as a 9mm carbide piece of the needle holder jaw plate.The defective needle was located, and the piece was retrieved from the patient.The piece fit the instrument which confirmed there were no additional missing pieces.An additional head imaging was obtained to verify that no other metallic items were unintentionally retained within the wound.The patient has recovered normally, with no additional consequences.

• Brand Name: SYMMETRY CLASSIC PLUS
• Common Device Name: NEEDLE HOLDER
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• Manufacturer (Section G): SYMMETRY SURGICAL INC; 3034 owen drive; antiioch TN 37013
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 16988862
• Report Number: 3007208013-2023-00018
• Device Sequence Number: 6872114
• Product Code: HXK
• UDI-Device Identifier: 00887482009871
• UDI-Public: 00887482009871
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2023

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: 36-3010
• Device Catalogue Number: 36-3010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2010
• 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