MAUDE Adverse Event Report: TYBER MEDICAL Ø2.0MM (6¿) DRILL

Model Number T001120116

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 04/29/2022

Event Type  malfunction  

Event Description

It was reported that the 1st drill bit broke and was left in patient(tip of drill).2nd drill bit started to break and doctor stopped using it.

Manufacturer Narrative

A device history record review was conducted for lot# 19155at08.There were no capas or non-conformances associated with this lot.The lot met all specifications.The lot consisted of 133 pieces.The lot met all specifications and was released.A historical data review for part number t001120116 spanning 18 months revealed 5 complaints in which 4 were for fractured instruments.There have been no similar complaints reported for the complaint type.A review of test report tr#201907 biocompatibility evaluation demonstrate that the drill material was biocompatible.Biocompatibility testing met the passing criteria.

• Brand Name: Ø2.0MM (6¿) DRILL
• Type of Device: DRILL
• Manufacturer (Section D): TYBER MEDICAL; 83 south commerce way; suite 310; bethlehem PA 18017
• Manufacturer (Section G): TYBER MEDICAL; 83 south commerce way; suite 310; bethlehem PA 18017
• Manufacturer Contact: mark schenk ; 83 south commerce way; suite 310; bethlehem, PA 18017 ; 8667610933
• MDR Report Key: 14567926
• MDR Text Key: 293723893
• Report Number: 3012966183-2022-00019
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/01/2022

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 Model Number: T001120116
• Device Catalogue Number: T001120116
• Device Lot Number: 19155AT08
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/11/2022
• Initial Date FDA Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other