MAUDE Adverse Event Report: I.T.S. GMBH DISTAL FEMUR PLATE, 13-HOLE, RIGHT

Model Number	21301-13
Medical Device Problem Codes	Fracture (1260); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have inspected the qc documents of the lot and the quality inspection forms as well as the material certificates showed no deviations and complies with the specifications.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.If further information gets available, as supplemental report will be filed.
Event or Problem Description
It was reported that a distal femur plate 13-hole broke approx.3 months post-op.Device used for diagnosis not known.

• Brand Name: DISTAL FEMUR PLATE, 13-HOLE, RIGHT
• Common Device Name: DISTAL FEMUR PLATE, 13-HOLE, RIGHT
• 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: 14426648
• Report Number: 3004369035-2022-00006
• Device Sequence Number: 12394751
• Product Code: HRS
• UDI-Device Identifier: 09120034307058
• UDI-Public: 09120034307058
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K093868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 05/17/2022

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: 21301-13
• Device Catalogue Number: 21301-13
• Device Lot Number: 26/F44183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 05/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Unknown
• Patient Weight: 130 KG