MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY VERITY; BALL TIP NERVE HOOK

Model Number	58-6063T
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is being returned for evaluation, but has not been received yet.This is the first complaint recorded for this product code.A follow up report will be submitted once we complete our evaluation.
Event or Problem Description
During an anterior cervical disectomy the ball tip of the nerve hook broke off.They noticed the damaged nerve hook after the procedure and sent the patient it imaging.The imaging confirmed that that the ball tip remained the patient.The doctor determined that an additional surgery was not necessary to remove the tip.
Additional Manufacturer Narrative
The devices were received and processed on 2/27/2023.The devices were then sent to the manufacturing location for additional review and evaluation.A follow up report will be submitted once we have received the evaluation report of the returned devices.
Additional Manufacturer Narrative
The returned devices were sent to the manufacturing location for further evaluation.Material: to manufacture this instrument was used ti-6al-4v, titanium grade 5 alloy (unsr56400).The chemical composition of which and quality certificate are attached.Workload test: for testing, instruments from the same lots (2204 and 2205) were used.They were subjected to the internal testing procedure on a tensile testing machine (the instrument handle was fixed motionless, and a force was applied to the working part along the instrument axis until reaching the breaking point.Each time the instrument's neck rupture occurred when the workload force was above 245n (55 pound-force).Conclusion: this is a microsurgical instrument, designed to work with microvascular and neural tissue, which does not imply the application of workload forces exceeding 105n (23.6 pound-force).Based on the purpose of the instrument, the rma report images and the internal workload testing, it was concluded that the instrument met quality standards and was not used for its intended purpose.If instrument was used as intended, the damage to the instrument proves there was some kind of mechanical force applied that caused the severe physical deformation prior to use.These delicate instruments are not malleable.They are designed for high precision microsurgical procedures.There should not be any dings, dents, or bends on these items.When the items look as these do, they should no longer be used.This type of instrument damage can be caused by drops and/or improper handling during the sterilization process, causing unforeseen instrument deformation which could get worse upon use.Based on the manufacturing locations evaluation, it can be determined that the root cause can be attributed to user error.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.
Additional Manufacturer Narrative
In the previous mdr submission 3007208013-2023-00006-02 section g4 was marked as combination product.This is incorrect and should have been selected.

• Brand Name: SYMMETRY VERITY
• Common Device Name: BALL TIP NERVE HOOK
• 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: 16421972
• Report Number: 3007208013-2023-00006
• Device Sequence Number: 14883534
• Product Code: GDG
• UDI-Device Identifier: 00887482103654
• UDI-Public: 00887482103654
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/05/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 58-6063T
• Device Catalogue Number: 58-6063T
• Device Lot Number: 2204380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/27/2023
• Supplement Date Received by Manufacturer: 01/27/2023; 01/27/2023; 01/27/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 03/22/2023; 04/28/2023; 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2022
• 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