MAUDE Adverse Event Report: EBI, LLC. BIOMET SPINALPAK / ORTHOPAK; 20" LEAD WIRES, REPLACEMENT

Model Number	1067724-2
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Codes	Shock (2072); Numbness (2415)
Date of Event	07/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow up report will be sent.
Event or Problem Description
It was reported that the patient had a tough time pulling the electrodes and lead wire prong apart so she used pliers and a silicon jar opener to pry them apart.She did not notice there was an issue with the prong but she got a shock down her arm so she examined the 20-inch lead wire and found exposed wires and a loose prong.It was later reported that the patient felt a strong electrical shock from her neck to her right arm.She also experiences tingling and slight numbness in the arm.The patient has not contacted her physician but has an appointment with her surgeon on (b)(6) 2024.The patient believes the shock was due to exposed wires in the 20-inch lead wire.
Additional Manufacturer Narrative
Investigation summary: the 20¿ lead wire was received for evaluation.The dhr was reviewed.All evaluation results did not show any discrepancies.During the investigation, the failure mode identified after examination of the patient lead wire was frayed.The most likely root cause for this failure mode was either caused by the excessive connecting/disconnecting force applied by the patient while connecting/disconnecting the lead wire cable from the electronic controller and/or the wire getting stuck in some object.Review of complaint history identified (2) total complaints from (jul 10, 2023) to (jul 10, 2024) for pn (1067724-2) and events related to (shock).Keyword search criteria: (complaint code: medical: shock) the search could not be specified further because the main complaint was pain.Review of the information provided by the customer and the findings from the investigation indicated that no physical and/or device functional condition could be found that could be considered a causal factor for the reported complaint of "shock".No failure and/or fault condition could be found and confirmed.Therefore, no further actions are required at this time.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Highridge medical will continue to monitor for trend.
Event or Problem Description
It was reported that the patient had a tough time pulling the electrodes and lead wire prong apart so she used pliers and a silicon jar opener to pry them apart.She did not notice there was an issue with the prong but she got a shock down her arm so she examined the 20-inch lead wire and found exposed wires and a loose prong.It was later reported that the patient felt a strong electrical shock from her neck to her right arm.She also experiences tingling and slight numbness in the arm.The patient has not contacted her physician but had an appointment with her surgeon on (b)(6) 2024.The patient believes the shock was due to exposed wires in the 20-inch lead wire.No additional patient consequences have been reported.The 20" lead wire was returned for further evaluation.

• Brand Name: BIOMET SPINALPAK / ORTHOPAK
• Common Device Name: 20" LEAD WIRES, REPLACEMENT
• Manufacturer (Section D): EBI, LLC.; 1 gatehall dr; suite 303; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC; 1 gatehall dr; suite 303; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 19905669
• Report Number: 0002242816-2024-00098
• Device Sequence Number: 7080227
• Product Code: LOF
• UDI-Device Identifier: 00812301020300
• UDI-Public: 00812301020300
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P850022
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1067724-2
• Device Catalogue Number: 1067716
• Device Lot Number: 2318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic