MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. ANCHOR BOLT

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2022

Event Type  malfunction  

Manufacturer Narrative

Complainant reported that the anchor bolt was discovered broken during electrode explant.An additional scan was completed to assess the bolt and it was removed successfully.Complainant stated that this only added an additional 20-30 minutes to the procedure and the patient was released next day (standard procedure).This patient was reported to having had extremely violent seizures during monitoring.No specific information regarding the anchor bolt catalog number, lot, or batch has been received by the user facility.The anchor bolt has not yet been returned.

Event Description

During explant of electrodes, an anchor bolt was found broken in the skull.Additional imaging and prolonged procedure was needed to remove the electrode from the skull.There was no patient harm.

Event Description

During explant of electrodes, an anchor bolt was found broken in the skull.Additional imaging and prolonged procedure was needed to remove the electrode from the skull.There was no patient harm.

Manufacturer Narrative

Complainant reported that the anchor bolt was discovered broken during electrode explant.An additional scan was completed to assess the bolt and it was removed successfully.Complainant stated that this only added an additional 20-30 minutes to the procedure and the patient was released next day (standard procedure).This patient was reported to having had extremely violent seizures during monitoring.No specific information regarding the anchor bolt catalog number, lot, or batch has been received by the user facility.The anchor bolt has not yet been returned.The user facility was unable to provide traceability information for the bolt and the return analysis was also unable to identify the model due to separated components.The root cause was inconclusive and may have been related to the angle of the bolt in the skull.The risk assessment concluded that the calculated occurence remains alap and no further action is needed at this time.

• Brand Name: ANCHOR BOLT
• Type of Device: ANCHOR BOLT
• 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: pamela stogsdill ; 400 west oakview parkway; oak creek, WI 53154 ; 2626341555
• MDR Report Key: 14414915
• MDR Text Key: 291834069
• Report Number: 2183456-2022-00014
• Device Sequence Number: 1
• Product Code: GZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

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
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 05/17/2022
• Supplement Dates Manufacturer Received: 04/20/2022
• Supplement Dates FDA Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other