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

Catalog Number LSBK1-BX-06

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

While tightening the anchor bolt in the operating room during placement an anchor bolt broke.Specific part information, details on removal of the bolt, and patient safety impact has not been received yet from the customer.

Event Description

While tightening a bolt in the operating room during placement, the anchor bolt broke.

• 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: 11016124
• MDR Text Key: 238830952
• Report Number: 2183456-2020-00027
• 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,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2020

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 Catalogue Number: LSBK1-BX-06
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/16/2020
• 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