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

Model Number	LSBK1-BX-05
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to customer checklist; the surgeon was using the new medtronic robot, the surgeon places the bolts through the reducing sleeve on the robot, versus removing the sleeve as some do.
Event or Problem Description
On (b)(6) 2024 two anchor bolts broke off during a seeg surgical procedure.The surgeon was required to drill around the site (location of the anchor bolt) to increase the size of the hole to remove the bolt and its smaller pieces.There was no patient harm or injury reported.
Additional Manufacturer Narrative
According to customer checklist; the surgeon was using the new medtronic robot, the surgeon places the bolts through the reducing sleeve on the robot, versus removing the sleeve as some do.Updated 03/08/2024.The product was returned for evaluation.The alleged complaint was confirmed that the anchor bolt was broken.The anchor bolt broke at the point it was designed to break.Breaking can occur from many things like excessive force when tightening, patient movement (seizures) during monitoring, etc.In this case, the bolts broke at removal but we are not able to determine when the damage leading to the break occurred.The calculated occurrence level matches the occurrence level present in the risk file and the resulting risk level will remain "alap".No further action is needed at this time.
Event or Problem Description
On (b)(6) 2024 two anchor bolts broke off during a seeg surgical procedure.The surgeon was required to drill around the site (location of the anchor bolt) to increase the size of the hole to remove the bolt and its smaller pieces.There was no patient harm or injury reported.
Additional Manufacturer Narrative
According to customer checklist, the surgeon was using the new medtronic robot, the surgeon places the bolts through the reducing sleeve on the robot, versus removing the sleeve as some do.Updated 03/08/2024: the product was returned for evaluation.The alleged complaint was confirmed that the anchor bolt was broken.The anchor bolt broke at the point it was designed to break.Breaking can occur from many things like excessive force when tightening, patient movement (seizures) during monitoring, etc.In this case, the bolts broke at removal but we are not able to determine when the damage leading to the break occurred.The calculated occurrence level matches the occurrence level present in the risk file and the resulting risk level will remain "alap".No further action is needed at this time."udi related data quality updates only" clarification and correction of the following missing items from previous supplemental report: combination product- no brand name- anchor bolt kit, lsb style model and catalog number lskb1-bx-05 primary di (b)(4).
Event or Problem Description
On (b)(6) 2024 two anchor bolts broke off during a seeg surgical procedure.The surgeon was required to drill around the site (location of the anchor bolt) to increase the size of the hole to remove the bolt and its smaller pieces.There was no patient harm or injury reported.

• Brand Name: ANCHOR BOLT KIT, LSB STYLE
• Common Device Name: LSB STYLE ANCHOR BOLTS
• 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: monique-elise alamina ; 400 west oakview parkway; oak creek, WI 53154 ; 2626341555
• MDR Report Key: 18660337
• Report Number: 2183456-2024-00003
• Device Sequence Number: 8002890
• Product Code: GZL
• UDI-Device Identifier: 00841823104281
• UDI-Public: 00841823104281
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2024

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 Model Number: LSBK1-BX-05
• Device Catalogue Number: LSBK1-BX-05
• Device Lot Number: 819820821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2024
• Supplement Date Received by Manufacturer: 01/15/2024; 01/15/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 03/08/2024; 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown