MAUDE Adverse Event Report: I.T.S. GMBH SPIRAL DRILL, D=2.5MM, L=220MM, AO CONNECTOR

Model Number 61253-220

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 05/05/2019

Event Type  malfunction  

Manufacturer Narrative

The device history record (dhr) of the last three shipments of the 61253-220 drill were inspected and showed no deviations.The quality forms met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing that would contribute to this complaint condition.A review of the raw material device history record revealed no deviation.The material was determined to be conforming and was used as is per product development approval.As a result of the above and the fact that no device was returned for evaluation and further information is missing, this complaint is deemed unconfirmed.Device was used for treatment, not diagnosis.

Event Description

It was reported that a spiral drill broke in two pieces intraoperatively.Surgery date is (b)(6) 2019.There were no delays in surgery.Broken part remains in patient.

• Brand Name: SPIRAL DRILL, D=2.5MM, L=220MM, AO CONNECTOR
• Type of Device: SPIRAL DRILL, D=2.5MM, L=220MM, AO CONNECTOR
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh?he, 8301 ; AU 8301
• Manufacturer (Section G): I.T.S. GMBH; autal 28; lassnitzh?he, 8301 ; AU 8301
• Manufacturer Contact: florian grill ; autal 28; lassnitzh?he, 8301 ; AU 8301
• MDR Report Key: 8756577
• MDR Text Key: 150279020
• Report Number: 3004369035-2019-00007
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 09120047301357
• UDI-Public: 09120047301357
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K051412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 61253-220
• Device Catalogue Number: 61253-220
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other