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

Catalog Number 627614

Device Problems Fracture (1260); Material Rupture (1546)

Patient Problem No Code Available (3191)

Event Date 03/19/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported by risk manager at the hospital, reported the following event : "rupture of the axsos titanium plate implanted on (b)(6) 2017.Pseudarthrosis.Revision of the plate.".

Event Description

It was reported by risk manager at the hospital, reported the following event : "rupture of the axsos titanium plate implanted on (b)(6) 2017.Pseudarthrosis.Revision of the plate.".

Manufacturer Narrative

The reported event that distal lateral femur plate axsos 3 ti for left femur 14 hole / l310mm was alleged of 'implant breakage after surgery' could be confirmed.More detailed information about the complaint event like x-rays, patient activity level, and patient characteristics must be available in order to determine the root cause of the complaint event.The device inspection revealed the following: the plate returned is indeed broken in two, at the level of the 5th circular hole.A microscope inspection shows that one of the two breakage surfaces is shiny, which proves that the two parts rubbed against each other before breaking.The second surface is rough, letting us know that it was the one that hold the two parts together until the final breakage pf the plate.This kind of fracture is characteristic of a fatigue fracture.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 investigation report will be updated.

• Brand Name: DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR LEFT FEMUR 14 HOLE / L310MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7397607
• MDR Text Key: 104404994
• Report Number: 0008031020-2018-00272
• 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
• Type of Report: Initial,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 627614
• Device Lot Number: V25097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Date Manufacturer Received: 05/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR