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

Catalog Number LSBK1-BX-05

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/11/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023 during surgery, an anchor bolt broke off while being inserted and some of it retained in the bone.The awareness date of this incident was (b)(6) 2023.There was no reported injury to the patient.A replacement bolt was used to continue the procedure.

Manufacturer Narrative

Based on our reportable decision assessment, it was determined that the severity of this issue calls for an mdr.While the customer reported no harm to the patient, removal of retained anchor bolt threads in the bone could require an additional surgical procedure with the possibility to cause damage to healthy tissue.Out of an abundance of caution an mdr will be filed.

Manufacturer Narrative

Based on our reportable decision assessment, it was determined that the severity of this issue calls for an mdr.While the customer reported no harm to the patient, removal of retained anchor bolt threads in the bone could require an additional surgical procedure with the possibility to cause damage to healthy tissue.Out of an abundance of caution an mdr will be filed.Updated on 6/28/2023: several attempts were made to follow-up with the doctor about the removal of the anchor bolt from the patient's skull.There has been no confirmation in regards to removal of the anchor bolt.There has been no further report of patient harm or injury.Ad-tech informed the doctor that the anchor bolts intended duration of use is < 30 days.

Event Description

On (b)(6) 2023 during surgery, an anchor bolt broke off while being inserted and some of it retained in the bone.The awareness date of this incident was 05-12-2023.There was no reported injury to the patient.A replacement bolt was used to continue the procedure.

• Brand Name: ANCHOR BOLT
• Type of Device: ANCHOR BOLT
• 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: 17003432
• MDR Text Key: 315946208
• Report Number: 2183456-2023-00006
• Device Sequence Number: 1
• Product Code: GZL
• Combination Product (y/n): Y
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2023

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 Catalogue Number: LSBK1-BX-05
• Device Lot Number: 153791
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 05/12/2023
• Supplement Dates FDA Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1