MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. MACRO DEPTH ELECTRODE

Model Number	BF08R-SP05X-000
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A request for additional information was sent on 01/03/2024 to the initial reporter to obtain details for the investigation.
Event or Problem Description
A medwatch report mw5149265 was received on 01/03/2024 in regards to a patient under going removal of a fractured electrode.Post-operative imaging demonstrated a retained fractured portion which required a return to the operating room for removal.
Additional Manufacturer Narrative
A request for additional information was sent on 01/03/2024 to the initial reporter to obtain details for the investigation.Updated 03/08/2024.No batch was identified, no device history record could be conducted.As ad-tech was notified of this event by the fda, very little information was provided via report (b)(4), while we were able to contact the customer and obtain a checklist, not enough information was provided to determine a root cause.The calculated occurrence level matches the occurrence level present in the risk file and the resulting risk level will remain "acceptable".No further action is needed at this time.
Event or Problem Description
A medwatch report mw5149265 was received on 01/03/2024 in regards to a patient under going removal of a fractured electrode.Post-operative imaging demonstrated a retained fractured portion which required a return to the operating room for removal.
Additional Manufacturer Narrative
A request for additional information was sent on 01/03/2024 to the initial reporter to obtain details for the investigation.Updated 03/08/2024.No batch was identified, no device history record could be conducted.As ad-tech was notified of this event by the fda, very little information was provided via report ms5149265, while we were able to contact the customer and obtain a checklist, not enough information was provided to determine a root cause.The calculated occurrence level matches the occurrence level present in the risk file and the resulting risk level will remain "acceptable".No further action is needed at this time."udi related data quality updates only".Updated 9/25/2024: clarification and correction of the following missing items from previous supplemental report: combination product- no brand name- macro depth electrode model number bf08r-sp05x-000 primary di number-(b)(4).Labeled for single use - yes.
Event or Problem Description
A medwatch report mw5149265 was received on 01/03/2024 in regards to a patient under going removal of a fractured electrode.Post-operative imaging demonstrated a retained fractured portion which required a return to the operating room for removal.

• Brand Name: MACRO DEPTH ELECTRODE
• Common Device Name: DEPTH ELECTRODE
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek WI 53154
• Manufacturer (Section G): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek WI 53154
• Manufacturer Contact: monique-elise alamina ; 400 west oakview parkway; oak creek, WI 53154 ; 2626341555
• MDR Report Key: 18487434
• Report Number: 2183456-2024-00002
• Device Sequence Number: 3690935
• Product Code: GZL
• UDI-Device Identifier: 00841823100504
• UDI-Public: 00841823100504
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K163355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2024

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: BF08R-SP05X-000
• Device Catalogue Number: BF08R-SP05X-000
• Device Lot Number: 828829830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 01/03/2024; 01/03/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 03/08/2024; 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: MW5149265
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown