MAUDE Adverse Event Report: I.T.S. GMBH TORQUE-SHANK, T7X80 CANNULATED, AO CONNECTOR

Model Number 54098-80

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

The device history record (dhr) of the last three shipments of the 61152-100 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.

Event Description

It was reported that a cannulated drill bit broke during surgery.

Manufacturer Narrative

The device history record (dhr) of the article 54098-80 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.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.

Event Description

It was reported that a screwdriver shank broke intraoperatively.

• Brand Name: TORQUE-SHANK, T7X80 CANNULATED, AO CONNECTOR
• Type of Device: TORQUE-SHANK, T7X80 CANNULATED, AO CONNECTOR
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh?he, styria 8301 ; AU 8301
• MDR Report Key: 9556852
• MDR Text Key: 198746178
• Report Number: 3004369035-2019-00017
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 09120047301128
• UDI-Public: 09120047301128
• Combination Product (y/n): N
• PMA/PMN Number: K131722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

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
• Device Operator: Health Professional
• Device Model Number: 54098-80
• Device Catalogue Number: 54098-80
• Device Lot Number: 27/0214
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/07/2020
• Supplement Dates Manufacturer Received: 12/31/2019
• Supplement Dates FDA Received: 01/14/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other