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

Catalog Number	68.76.84
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2018
Type of Reportable Event	Malfunction
Additional 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.Additional information has been requested regarding the handpiece and the rotational speed used during the operation.[(b)(4)].
Event or Problem 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 #2 of 2 used during the same procedure.

• Brand Name: TWIST DRILL
• Common Device Name: DRILL
• Manufacturer (Section D): MEDICON E.G.; gaensaecker 15; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 8580699
• Report Number: 8010099-2019-00008
• Device Sequence Number: 1809516
• Product Code: HWE
• UDI-Device Identifier: 04046826312350
• UDI-Public: 04046826312350
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2019

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: 68.76.84
• Device Lot Number: PF17245
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 05/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1