MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. ANCHOR BOLTS; ANCHOR BOLT (ACCESSORY TO DEPTH ELECTRODES)

Catalog Number	LSBK1-AX-06
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An internal complaint investigation was performed for this issue.Specifically, a historical complaints review was completed for the alleged deficiency "broken anchor bolts".There have been 13 similar complaints for anchor bolts breaking between january 1, 2017 and march 18, 2019.A capa and investigation review was also conducted for the alleged deficiency "anchor bolt broke during implantation" and there have been no capas or investigations opened for this issue to date.A batch record review was conducted; (b)(4) lsbk1-ax-06 anchor bolts were planned for this work order and (b)(4) were completed.No issues were noted in the work order process notes that would contribute to the reported complaint.All (b)(4) lsbk1-ax-06 anchor bolts passed the in-process and final qc checks.No product return analysis could be performed for this complaint as no product was returned.According to the customer's sales representative, the patient's skull was thicker and required more force to place the bolt.The neurosurgeon was more aggressive when attempting to insert (i.E., screw in) this bolt into the skull; thus resulting in the bolt snapping.The risk level for this issue remains alap (as low as possible).Additionally, based on a review of previous complaints for anchor bolt breakages and an analysis of all anchor bolt breakage complaint data, the current rate of anchor bolt breakage complaints versus products sold is very low; (b)(4) over the past 2 years.Ad-tech is continuing to monitor this issue closely.
Event or Problem Description
On march 15, 2019, ad-tech received a copy of a medwatch 3500a report from the food and drug administration (fda).The report was from a user facility (uf), documented under uf report # (b)(4).According to the form, it was stated that, ".When inserting the anchor bolt, the bolt snapped." part of the bolt remained in the skull and a needle driver was used to secure the anchor bolt, thus enabling the bolt to be unscrewed for removal.According to the user facility, they were not aware of any other information about the patient that may have influenced the outcome of the event.

• Brand Name: ANCHOR BOLTS
• Common Device Name: ANCHOR BOLT (ACCESSORY TO DEPTH ELECTRODES)
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek 53154
• MDR Report Key: 8472930
• Report Number: 2183456-2019-00001
• Device Sequence Number: 13855982
• Product Code: GZL
• UDI-Device Identifier: 90841823104277
• UDI-Public: (01)90841823104277(17)200601(10)0121088208140678
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K181544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2019
• Report Date (Section F): 03/15/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2020
• Device Catalogue Number: LSBK1-AX-06
• Device Lot Number: 208140678/0121088
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 21 YR