MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FEMUR PLATE AXSOS 3 FOR LEFT FEMUR 16 HOLE / L343MM; PLATE, FIXATION, BONE

Model Number 627616S

Device Problems Break (1069); Fracture (1260)

Patient Problems Failure of Implant (1924); Implant Pain (4561)

Event Date 09/14/2022

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

The patient reported pain in the lower limb and on x-ray analysis the fixation device was broken.The patient required a revision surgery.

Manufacturer Narrative

Please note the correction to d9/h3 as the device was not returned for evaluation.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition unknown.

Event Description

The patient reported pain in the lower limb and on x-ray analysis the fixation device was broken.The patient required a revision surgery.

Event Description

The patient reported pain in the lower limb and on x-ray analysis the fixation device was broken.The patient required a revision surgery.

Manufacturer Narrative

Correction - please refer to d9/h3, h6 - method, results & conclusion codes.The reported event could be confirmed, since the plate is broken apart as complained.The device inspection revealed the following: the visual inspection has shown that the plate is broken apart in the middle of the shaft at a locking hole.There are scratches all over the plate, but afterwards it cannot be defined if these damages were caused during insertion or extraction.The microscopic examination of the fracture surface reveals the fracture to be a typical fatigue fracture evident by a smooth topography.Lines of rest are visible on both sides of the fracture, starting on the top corners of the hole.There are shiny surfaces on both fracture faces, which indicates that the fragments rubbed against each other after the breakage.The rest of the fracture face has the typical view of a fatigue fracture with an uniform fine-grained texture.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.No product related issue could be detected.There was no additional information, like x-rays, operation reports, implant date, patient history or activity, provided.Therefore the root cause of the breakage cannot be defined.The evaluation of the plate has shown that fatigue did lead to the breakage of the device.In this relation following statement of the axsos 3 implants instructions for use can be mentioned: ¿the implant is intended for temporary bone fixation.In the event of a delay in bone consolidation, or if such consolidation does not take place, or if explantation is not carried out, complications may occur, for example fracture or loosening of the implant or instability of the implant system.Regular postoperative examinations (e.G.X-ray checks) are advisable" if more information is provided, the case will be reassessed.

• Brand Name: DISTAL LATERAL FEMUR PLATE AXSOS 3 FOR LEFT FEMUR 16 HOLE / L343MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15649509
• MDR Text Key: 302166023
• Report Number: 0008031020-2022-00558
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 04546540685711
• UDI-Public: 04546540685711
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K200398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 627616S
• Device Catalogue Number: 627616S
• Device Lot Number: H3665S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2021
• 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
• Patient Age: 39 YR