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

Catalog Number LSBK2-BX-04

Device Problem Flaked (1246)

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

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

Mdr 2183456-2020-00018 has been filed past the 30-day timeframe.Through the 2019 fda inspection, it was identified that while ad-tech was evaluating reportability for actual events in which death or serious injury had occurred, ad-tech had failed to submit events in which a malfunction was reported and could result in a serious injury if the event were to recur.As part of the investigation, a two (2) year retrospective review of complaints was performed to determine which complaints required submission of an mdr.While the out of specification condition associated with this report was identified by the surgeon prior to use, recurrence of this issue could potentially impact patient safety if the burr were to make patient contact and remain in situ following the intended surgical operation.

Event Description

On (b)(6) 2018, ad-tech received a complaint from a customer stating that the surgeon identified "fuzz" (burr) in one (1) ad-tech anchor bolt on 5/29/2018.The lot and batch numbers were not specified in the original report and were not provided to ad-tech during follow-up request.No known impact to patient safety as the issue was identified prior to use.

• Brand Name: ANCHOR BOLT
• Type of Device: ANCHOR BOLT
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek, wi
• Manufacturer (Section G): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek, wi
• Manufacturer Contact: kathleen barlow ; 400 west oakview parkway; oak creek, wi ; 6341555301
• MDR Report Key: 9732953
• MDR Text Key: 186564812
• Report Number: 2183456-2020-00018
• 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: company representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 02/19/2020

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: LSBK2-BX-04
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2018
• Initial Date FDA Received: 02/20/2020
• 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