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

Catalog Number	LSBK2-BX-04
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 2183456-2020-00017 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 or Problem Description
On 5/18/2018, an ad-tech representative informed the ad-tech chief operating officer of a situation in which burrs were identified on ad-tech anchor bolt.There was no known impact to patient safety.

• Common Device Name: ANCHOR BOLT
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek, wi
• MDR Report Key: 9732913
• Report Number: 2183456-2020-00017
• Device Sequence Number: 2352967
• Product Code: GZL
• UDI-Device Identifier: 90841823104345
• UDI-Public: (01)90841823104345(17)191201(10)0116520208140661
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/12/2019
• Device Catalogue Number: LSBK2-BX-04
• Device Lot Number: 208140661 (0116520)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1