MAUDE Adverse Event Report: I.T.S. GMBH DISTAL FEMUR PLATE, 9-HOLE, LEFT

Model Number	21302-9
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Malunion of Bone (4529)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have inspected the dhf of the affected lot including 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.The implant failure occurred due to delayed fracture healing and due to a fall.Based on the information available, it has been determined that no corrective and preventative action is proposed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that a distal femur plate 9-hole broke approx.6 months post-operatively.Upon investigation, it has been revealed that the patient fell which caused the plate breakage.

• Brand Name: DISTAL FEMUR PLATE, 9-HOLE, LEFT
• Common Device Name: DISTAL FEMUR PLATE, 9-HOLE, LEFT
• 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; lassnitzhöhe, 8301 ; AU 8301
• MDR Report Key: 17235118
• Report Number: 3004369035-2023-00009
• Device Sequence Number: 5642586
• Product Code: HRS
• UDI-Device Identifier: 09120034307072
• UDI-Public: 09120034307072
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K093868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2023

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: Health Professional
• Device Model Number: 21302-9
• Device Catalogue Number: 21302-9
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Unknown
• Patient Weight: 90 KG