MAUDE Adverse Event Report: I.T.S. GMBH SPIRAL DRILL, D=2.7MM, L=100MM, AO CONNECTOR

Model Number	61273-100
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/05/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) of the drill 61273-100 was 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.We investigated the drill and detected abrasions 3-4cm above the tip, possibly caused by lateral force when using the drill with the drill guide.Due to overuse of the drill, the cutting edge gets blunt.This results that the user must expend more strength and the drill breaks at the upper edge of the drill guide.Basically, the spiral drill is intended for multiple use, but care must be taken before usage, if the drill has any visual defect/damage due to wear, misuse or improper care (extract of our reconditioning manual).
Event or Problem Description
It was reported that a spiral drill broke in two pieces intraoperatively.Surgery date is unknown.There were no delays in surgery.

• Brand Name: SPIRAL DRILL, D=2.7MM, L=100MM, AO CONNECTOR
• Common Device Name: SPIRAL DRILL, D=2.7MM, L=100MM, AO CONNECTOR
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• MDR Report Key: 8225870
• Report Number: 3004369035-2015-00006
• Device Sequence Number: 10811835
• Product Code: HTW
• UDI-Device Identifier: 09120069814774
• UDI-Public: 09120069814774
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K050852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 61273-100
• Device Catalogue Number: 61273-100
• Device Lot Number: 24/777247
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2015
• Initial Report FDA Received Date: 01/08/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention