MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR LEFT FEMUR 10 HOLE / L238MM; PLATE, FIXATION, BONE

Model Number	627610
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348); No Code Available (3191)
Date of Event	07/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Surgeon reported broken axsos plate which resulted in revision surgery.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the visual inspection revealed that the plate is broken; therefore, the fracture was analyzed.The investigation determined the following: -the initial fracture occurred in fatigue.-there were multiple damage locations at and near the fracture origin giving a clear source of how the fracture propagated.-at the fracture origin and along the fracture plane contains no evidence of inclusions or anomalies that would question the material.No impurities like w, tungsten or heavy oxides were detected.Therefore, the material is fully responding to stryker's quality requirement.Moreover, the medical records were received and were reviewed by stryker¿s medical expert, and his clinical opinion pertaining to this case indicated the following: "the plate used seems to be short for this type of fracture.It is very difficult for a patient to properly address the weightbearing instructions.This is especially true at older age, or when they already have a problem with walking (e.G.Due to comorbidities).The need for a physiotherapist to help is highly recommended and depending on the ability and comorbidity of the patient, even an admission to a rehabilitation center could be required.Too much weight on this construction earlier in the healing phase can easily be a reason for the plate breakage to occur only a young and fit patient, might have been able to work on the rehabilitation with 20% weight bearing after six weeks." to conclude on the clinical view, the reason for the breakage might be due the construct in combination with to early weightbearing.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 any further information is provided, the complaint report will be updated.
Event or Problem Description
Surgeon reported broken axsos plate which resulted in revision surgery.

• Brand Name: DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR LEFT FEMUR 10 HOLE / L238MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8908306
• Report Number: 0008031020-2019-01065
• Device Sequence Number: 10891265
• Product Code: HRS
• UDI-Device Identifier: 07613252579571
• UDI-Public: 07613252579571
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K181091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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: 627610
• Device Catalogue Number: 627610
• Device Lot Number: Y55829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR