MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORPORATION ANCHOR BOLT-LSB STYLE

Catalog Number	LSBK1-AX-05
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As stated in the event description, ad-tech was made aware of an issue on (b)(6) 2017.During an seeg/rosa depth case, while attempting to place an anchor bolt for one of the trajectories the bolt broke.The doctor stated that the bone was thick and when attempting to screw the bolt into the bone, some resistance was felt and the wrench started to turn very easily.At this point it was identified that the base of the anchor bolt broke off at the top of the threads.An incision and a slight craniectomy had to be made to retrieve the broken bolt and some of the bolt was left behind.The doctor stated that no serious injury occurred.To date, multiple attempts have been made to obtain additional information.Ad-tech has not received any responses.Although the product was not sent back to ad-tech for evaluation, a picture was sent showing the broken bolt.Based on the picture, the alleged deficiency was confirmed in the complaint.This investigation is still on-going.
Event or Problem Description
Ad-tech was made aware of an issue on (b)(6) 2017.During an seeg/rosa depth case, while attempting to place an anchor bolt for one of the trajectories the bolt broke.The doctor stated that the bone was thick and when attempting to screw the bolt into the bone, some resistance was felt and the wrench started to turn very easily.At this point it was identified that the base of the anchor bolt broke off at the top of the threads.An incision and a slight craniectomy had to be made to retrieve the broken bolt and some of the bolt was left behind.According to the doctor, there was no serious injury to the patient as a result of this issue.

• Brand Name: ANCHOR BOLT-LSB STYLE
• Common Device Name: ANCHOR BOLT-LSB STYLE
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORPORATION; 1901 william street; racine WI 53404
• MDR Report Key: 6867065
• Report Number: 2183456-2017-00007
• Device Sequence Number: 809715
• Product Code: GCZ
• UDI-Device Identifier: 00841823104267
• UDI-Public: (01)00841823104267(17)181001(10)0103573208140625
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2017

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: 10/01/2018
• Device Catalogue Number: LSBK1-AX-05
• Device Lot Number: 208140625
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 09/14/2017
• 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