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

Model Number	54098-80
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: TORQUE-SHANK, T7X80 CANNULATED, AO CONNECTOR
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• MDR Report Key: 8230403
• Report Number: 3004369035-2016-00007
• Device Sequence Number: 1887529
• Product Code: LRZ
• UDI-Device Identifier: 09120047301098
• UDI-Public: 09120047301098
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K131722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2019

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: No Information
• Device Model Number: 54098-80
• Device Catalogue Number: 54098-80
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2016
• Initial Report FDA Received Date: 01/09/2019
• Patient Sequence Number: 1