MAUDE Adverse Event Report: DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR RIGHT FEMUR 8 HOLE / L202MM; PLATE, FIXATION, BONE

Model Number	627638
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Limb Fracture (4518); Unequal Limb Length (4534)
Date of Event	07/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The customer reported that: "mrs p-mh received an axsos plate ref 627638 lot d19852 on (b)(6) 2020 following a supra-condylar femur fracture dt.On (b)(6) 2021, while climbing a staircase, the patient fell and felt a crack.The ct scan of (b)(6) showed a fracture of the femoral plate and a 2 cm shortening of the femur with an engaged fracture.The patient was operated on again on (b)(6): removal of the plate and a new osteosynthesis by plate and graft decortication.".
Event or Problem Description
The customer reported that: "mrs p-mh received an axsos plate ref 627638 lot d19852 on (b)(6) 2020 following a supra-condylar femur fracture dt.On (b)(6) 2021, while climbing a staircase, the patient fell and felt a crack.The ct scan of (b)(6) showed a fracture of the femoral plate and a 2 cm shortening of the femur with an engaged fracture.The patient was operated on again on 04.08: removal of the plate and a new osteosynthesis by plate and graft decortication.".
Additional Manufacturer Narrative
D9 / h3 updated to indicate device was not returned the reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition is unknown.

• Brand Name: DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR RIGHT FEMUR 8 HOLE / L202MM
• Common Device Name: PLATE, FIXATION, BONE
• MDR Report Key: 12385645
• Report Number: 0008031020-2021-00387
• Device Sequence Number: 11696979
• Product Code: HRS
• UDI-Device Identifier: 07613252579656
• UDI-Public: 07613252579656
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K200398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 627638
• Device Catalogue Number: 627638
• Device Lot Number: D19852
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 10/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention