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

Catalog Number	LSBK1-AX-05
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	08/08/2018
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 thirteen similar complaints for anchor bolts breaking between january 1, 2016 and august 14, 2018.A capa and investigation review was also conducted for the alleged deficiency "anchor bolts (2) broke-1 during & 1 after implantation" and there have been no capas or investigations opened for this issue to date.A batch record review was conducted; 50 lsbk1-ax-05 anchor bolts were planned for this work order and 50 were completed.No issues were noted in the work order process notes that would contribute to the reported complaint.The 50 lsbk1-ax-05 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.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 august 14, 2018 ad-tech's clinical specialist received a phone call from a customer stating that 2 anchor bolts had sheared off at the threads.One bolt had sheared off while being screwed into the skull during implantation and the neurosurgeon drilled out the threaded portion.The second sheared bolt was found 6 days post-op.The threads still remain in the skull and will be drilled out during ex-plantation.To date, it is unknown what the current status is of the patient.It was stated that specific to the sheared bolt seen during implantation, the trajectory was scrapped and re-planned.

• Brand Name: ANCHOR BOLT - LSB STYLE
• Common Device Name: ANCHOR BOLT - LSB STYLE
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek 53154
• MDR Report Key: 7873064
• Report Number: 2183456-2018-00006
• Device Sequence Number: 18878066
• Product Code: GCZ
• UDI-Device Identifier: 90841823104260
• UDI-Public: (01)90841823104260(17)200601(10)0121399208140678
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/13/2018

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: 06/14/2018
• Device Catalogue Number: LSBK1-AX-05
• Device Lot Number: 208140678
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 09/13/2018
• 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