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

Model Number 54098-80

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The device history record (dhr) of the last three shipments of the screwdriver shank 54098-80 and the resp.Screws that were send to general care 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.We have tested the shank with multiple hcs screws from our stock and the shank engaged smoothly in the torque-profile.No deviation resp.Non-conformance detected.

Event Description

It was reported that a headless compression screw was mismatching with the torque shank.The incident didn't happen in surgery.

• 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
• Manufacturer (Section G): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• Manufacturer Contact: florian grill ; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• MDR Report Key: 8230403
• MDR Text Key: 132810585
• Report Number: 3004369035-2016-00007
• Device Sequence Number: 1
• Product Code: LRZ
• UDI-Device Identifier: 09120047301098
• UDI-Public: 09120047301098
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131722
• 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: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 54098-80
• Device Catalogue Number: 54098-80
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1