MAUDE Adverse Event Report: I.T.S. GMBH ULNA OSTEOTOMY PLATE, 6-HOLE

Model Number	21231-6
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have inspected the dhf of the lot and the material certificate and the batch was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.The article met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Based on the information available, no final conclusion could be drawn and it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This report does not reflect a conclusion by fda, i.T.S.Gmbh or its employees that the report constitutes an admission that the device caused or contributed to the potential event described in this report.This is report 1/2.
Event or Problem Description
It was reported that a non-locking screw backed out approx.5 weeks after surgery.In addition the two distal locking screws show signs of loosening in the bone, but are still locked in the plate.A second surgery was necessary.

• Brand Name: ULNA OSTEOTOMY PLATE, 6-HOLE
• Common Device Name: ULNA OSTEOTOMY PLATE,
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzhoehe, styria 8301 ; AU 8301
• Manufacturer (Section G): I.T.S. GMBH; autal 28; lassnitzhoehe, styria 8301 ; AU 8301
• Manufacturer Contact: florian grill ; autal 28; lassnitzhoehe, styria 8301 ; AU 8301
• MDR Report Key: 19124388
• Report Number: 3004369035-2024-00003
• Device Sequence Number: 15384086
• Product Code: HRS
• UDI-Device Identifier: 09120069811629
• UDI-Public: 09120069811629
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2024

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: 21231-6
• Device Catalogue Number: 21231-6
• Device Lot Number: 643/022310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Unknown