MAUDE Adverse Event Report: ABBOTT MEDICAL GUARDIAN¿ SCREW, 5MM, BURR HOLE COVER; DBS BUR HOLE COVER SCREW

Model Number	6015
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following the completion of the dbs implant procedure it was found that an expired guardian screw was opened by the circulator and implanted by the physician.Surgical intervention may be undertaken to address this issue.
Additional Manufacturer Narrative
An expired butt hole cap screw was reported to abbott.The issue was noted while reviewing product packaging after the operation was complete.Based on the information received, the event is consistent with the unintentional use of expired product.Additionally, the device history record of the device was reviewed to confirm that all manufacturing steps were completed and there were no non-conformances noted that could have contributed to this issue.Actions have been taken to prevent reoccurrence via capa 132510.

• Brand Name: GUARDIAN¿ SCREW, 5MM, BURR HOLE COVER
• Common Device Name: DBS BUR HOLE COVER SCREW
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 15765099
• Report Number: 1627487-2022-06111
• Device Sequence Number: 6353503
• Product Code: MHY
• UDI-Device Identifier: 05414734403078
• UDI-Public: 05414734403078
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/11/2022
• Device Model Number: 6015
• Device Catalogue Number: 6015
• Device Lot Number: 7616593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2022
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 08/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2020
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DBS BURR HOLE CAP (2); DBS LEAD (2)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 82 KG