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

Catalog Number 627640S

Device Problem Break (1069)

Patient Problem Fall (1848)

Event Date 05/15/2017

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device remains implanted.

Event Description

It was reported that plate broke due to fall down.

Manufacturer Narrative

The reported incident that distal lateral femur plate axsos 3 ti for right femur 10 hole / l238mm was alleged of issue s-12 (implant breakage after surgery) could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.A review of the labeling did not indicate any abnormalities.As per ifu (v15013_non active implant ifu ot-ifu-105): ¿no fracture fixation device that is subject to material fatigue can be expected to withstand activity levels in the same way as would a normal healthy bone.The fracture fixation system, therefore, will not be as strong, reliable or durable as a normal human bone.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.Post-operative: post-operative patient activity: these implants are neither intended to carry the full load of the patient acutely, nor intended to carry a significant portion of the load for extended periods of time.For this reason post-operative instructions and warnings to patients are extremely important.Informing the patient: the implantation affects the patient¿s ability to carry loads and her/his mobility and general living circumstances.For this reason, the surgeon must counsel each patient individually on correct behavior and activity after the implantation.The surgeon must warn patient that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity, trauma, mal-union or non-union and that the device has a finite expected service life and may need to be removed at some time in the future.¿ based on investigation, the root cause could be attributed to patient related issue due to the implant being subjected to sudden excessive load while fall down.The labelling on the package warns of these complications and all possible patient activities which could lead to fracture / loosening or breakage of the implant.Patient details like age, height, weight etc are unknown.No x-rays showing type of fracture and plate breakage were returned.Most likely the patient¿s fall resulted in the plate breakage, however, this cannot be conclusively determined with the available information.A review of the device history record for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.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.

Event Description

It was reported that plate broke due to fall down.

• Brand Name: DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR RIGHT FEMUR 10 HOLE / L238MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6625530
• MDR Text Key: 77188219
• Report Number: 0008031020-2017-00352
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K123964
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 627640S
• Device Lot Number: V17856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention