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

Device Problems Delivered as Unsterile Product (1421); Off-Label Use (1494)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

As stated in the event description on june 12, 2019 information was brought to the ad-tech medical instrument corporation regulatory team in regards to the possibility of anchor bolts being distributed non-sterile and sterilized at the site via sterrad sterilization.It was stated that three different occasions between (b)(6) 2019 and (b)(6) 2019 ad-tech personnel have distributed non-sterile anchor bolt parts to one independent representative and one international distributor, who may have subsequently sterilized the non-sterile anchor bolts for clinical use.Ad-tech does not have regulatory clearance to distribute non-sterile anchor bolts and does not have a validated hospital sterilization method for these devices.Further, ad-tech labeling does not include instructions for sterilizing anchor bolts as ad-tech sterilizes the anchor bolts via ethylene oxide (eto) sterilization prior to distribution.Ad-tech also received a picture of an ad-tech lsb style anchor bolt in a sterrad pouch in an operating room.A recall is being initiated for this issue.

Event Description

On june 12, 2019 ad-tech was made aware that on 3 different occasions between (b)(6) 2019 and (b)(6) 2019 ad-tech personnel had distributed non-sterile anchor bolt parts to one independent representative and one international distributor, who may have subsequently sterilized the non-sterile anchor bolts for clinical use.Ad-tech does not have regulatory clearance to distribute non-sterile anchor bolts and does not have a validated hospital sterilization method for these devices.Further, ad-tech labeling does not include instructions for sterilizing anchor bolts as ad-tech sterilizes the anchor bolts via ethylene oxide (eto) sterilization prior to distribution.

• Brand Name: LSB STYLE ANCHOR BOLTS
• 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: kathleen barlow ; 400 west oakview parkway; oak creek, WI 53154 ; 2626341555
• MDR Report Key: 8748079
• MDR Text Key: 149638152
• Report Number: 2183456-2019-00005
• Device Sequence Number: 1
• Product Code: GZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163355
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/21/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/13/2019
• Initial Date FDA Received: 07/01/2019
• 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
• Patient Outcome(s): Other