MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR RIGHT FEMUR 14 HOLE / L310MM; PLATE, FIXATION, BONE

Catalog Number	627644
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Information (3190); No Code Available (3191)
Date of Event	12/02/2018
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
As reported on maude report mw5077828-1 "patient had a second revision due to broken plate.Internal femoral rod was implanted".
Event or Problem Description
As reported on maude report mw5077828-1 " patient had a second revision due to broken plate.Internal femoral rod was implanted.".
Additional Manufacturer Narrative
The reported event could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by poor fracture reduction.As a reminder, the event reported in this complaint followed different stages that can be summarized as follows: on (b)(6) 2017, the patient had to be treated for a distal femur spiral fracture, with an axsos plate (627642).A short gamma nail was always present in the patient¿s body at that time.All the pre-operative x-rays showing the femur fracture (dated on (b)(6) 2017) could be extracted from the cd provided by the patient, as well as the intra-operative / post operative x-rays after the plate was implanted (all taken on (b)(6) 2017).On (b)(6) 2018, the patient was operated due to the breakage of the previously mentioned axsos plate.The broken plate was removed, and a second distal femoral compression plate (427644) was implanted.The x-rays dated on (b)(6) march show the results of the 1st revision.On (b)(6) 2018, the patient was admitted once again because of pain, and it turned out that the second axsos plate also broke.X-rays showing the breakage of this second plate were also provided, with the date of the (b)(6) 2018.On (b)(6) 2018, all the hardware was removed, and was replaced with a long gamma nail (3425-1320s).Since operative reports, patient discharge letter and x-rays were reviewed.As a conclusion, the reported cases of axsos breakages are due to inadequate fracture reduction and insufficient operative strategy from the health care professional.The ifu reminds the user to "ensure that you are familiar with the intended uses, indications/ contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system.Please remember that product systems may be subject to alterations that affect the compatibility of the implant with other implants or with instruments." 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.

• Brand Name: DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR RIGHT FEMUR 14 HOLE / L310MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8388720
• Report Number: 0008031020-2019-00141
• Device Sequence Number: 1525025
• Product Code: HRS
• UDI-Device Identifier: 07613252579687
• UDI-Public: 07613252579687
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K181091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2019

1 Device was Involved in the Event

2 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 Catalogue Number: 627644
• Device Lot Number: V03038
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 0
• Outcome Attributed to Adverse Event: Required Intervention