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

Model Number LSB ANCHOR BOLT

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

While placing anchor bolts during a case in (b)(6) 2021 in the thicker bone region, while tightening the bolt it did not continue to penetrate and it locked up causing it to fracture.The remaining piece was removed easily without additional intervention, and there was no impact to the patient.

Event Description

While placing anchor bolts during a case in (b)(6) 2021 in the thicker bone region, while tightening the bolt it did not continue to penetrate and it locked up causing it to fracture.The remaining piece was removed easily without additional intervention, and there was no impact to the patient.

• Brand Name: LSB ANCHOR BOLT
• Type of Device: 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: nicole remer ; 400 west oakview parkway; oak creek, WI 53154 ; 2626341555
• MDR Report Key: 11666169
• MDR Text Key: 246724968
• Report Number: 2183456-2021-00002
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/14/2021

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
• Device Model Number: LSB ANCHOR BOLT
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 04/14/2021
• 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