MAUDE Adverse Event Report: MEDICON E.G. TWIST DRILL

Catalog Number 68.76.84

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2018

Event Type  malfunction  

Manufacturer Narrative

The device history record was checked and conformed to specifications, including device hardness.The returned device was inspected and found to have fractured at the weakest spot, the thread run-out.Dimensions were verified and conform to specifications.The microstructure of the drill is homogenous and shows no anomalies.The drill core was measured at the fracture point and found to conform to specifications.The fracture surface reveals that the drill was strongly bent, as can occur when a drill is positioned obliquely or subject to excessive torsion force during use.Bone residue was found in the thread run-out area, indicating that the drill did not fracture immediately as stated.Additional information has been requested regarding the handpiece and the rotational speed used during the operation.[(b)(4)].

Event Description

In accordance with the surgeon's report, during plastic surgery he attempted to use a twist drill, but the device broke immediately.It was replaced by an identical drill bit from the same lot, which also broke immediately.The fractured tip of the second drill was deflected by the bone and flew at the surgeon's face, barely missing his eye.No patient harm.This report is for device #1 of 2 used during the same procedure.

• Brand Name: TWIST DRILL
• Type of Device: DRILL
• Manufacturer (Section D): MEDICON E.G.; gaensaecker 15; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): MEDICON E.G.; gaensaecker 15; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anton mittermueller ; gaensaecker 15; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 8580688
• MDR Text Key: 145769897
• Report Number: 8010099-2019-00007
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 04046826312350
• UDI-Public: 04046826312350
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 68.76.84
• Device Lot Number: PF17245
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1