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

Catalog Number	DDK2-2.4-30X
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On december 1, 2019, ad-tech received a complaint that two drill bits broke during surgery while attempting an oblique angle with a rosa.Both bits were retrieved and there was no impact to the patient.In further communication with the customer it was discovered that the bits broke on similar, but opposite trajectories and the drilling was performed by different individuals.There was no report of seizing in the guide.During the examination of the broken drill bits, there were no indications of excessive wear on the drill bit.
Event or Problem Description
On december 1, 2019, ad-tech received a complaint that two drill bits broke during surgery while attempting an oblique angle with a rosa.Both bits were retrieved and there was no impact to the patient.

• Brand Name: DRILL BIT
• Common Device Name: DRILL BIT
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek WI 53154
• MDR Report Key: 9263201
• Report Number: 2183456-2019-00042
• Device Sequence Number: 19346583
• Product Code: HBE
• UDI-Device Identifier: 90841823101160
• UDI-Public: (01)90841823101160(17)200701(10)0122649208140683
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: DDK2-2.4-30X
• Device Lot Number: 208140683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 10/31/2019
• 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