MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. DRILL KIT

Model Number	DDK2-2.4-30X
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 2183456-2020-00003 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.
Event or Problem Description
On april 17, 2018, ad-tech received a report from a user facility that product was found with compromised sterile barrier.The product was discarded and there was no impact to patient.

• Brand Name: DRILL KIT
• Common Device Name: DRILL KIT
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek WI 53154
• MDR Report Key: 9644909
• Report Number: 2183456-2020-00003
• Device Sequence Number: 19565080
• Product Code: HBE
• UDI-Device Identifier: 00841823101167
• UDI-Public: (01)00841823101167(17)190501(10)0109093208140642
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/29/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2019
• Device Model Number: DDK2-2.4-30X
• Device Catalogue Number: DDK2-2.4-30X
• Device Lot Number: 208140642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other