MAUDE Adverse Event Report: STRYKER GMBH DISTAL ANTEROLATERAL TIBIA PLATE AXSOS 3 TI FOR LEFT TIBIA 12 HOLE / L203MM; PLATE, FIXATION, BONE

Catalog Number 627462

Device Problem Fracture (1260)

Patient Problem Arthritis (1723)

Event Date 09/10/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The hospital reported the following event : "during radiographic inspection at 9 months of osteosynthesis shows a pseudoseptic osteoarthritis of the left tibia with fracture of the osteosynthesis plate (placed on (b)(6) 2018 following an open fracture in the left leg).Provisional measures and actions taken: need for surgical resumption on (b)(6) 2018 with removal of the material, samples, first time mask with spacer in cement fixation by external fixator and antibiotic therapy.The device has been retained for expertise.Clinical consequences noted: need for surgical resumption and septic pseudarthrosis.".

Event Description

The hospital reported the following event : "during radiographic inspection at 9 months of osteosynthesis shows a pseudoseptic osteoarthritis of the left tibia with fracture of the osteosynthesis plate (placed on 18/01/2018 following an open fracture in the left leg).Provisional measures and actions taken: need for surgical resumption on 21/09/2018 with removal of the material, samples, first time mask with spacer in cement fixation by external fixator and antibiotic therapy.The device has been retained for expertise.Clinical consequences noted: need for surgical resumption and septic pseudarthrosis.".

Manufacturer Narrative

The reported event that distal anterolateral tibia plate axsos 3 ti for left tibia 12 hole / l203mm was alleged of 'implant breakage after surgery' could be confirmed.Based on investigation, the root cause was attributed to be patient related.The failure was caused by an overloading/ precocious weightbearing on the implant.Indeed, the device inspection revealed the following: the plate's shaft is not flat as it is normally, but twisted around the longitudinal side of the plate.This bending of the plate is probably due to some torsional forces that were applied to the plate post-operatively, since no marks are visible on the plate surface that could lead to think that the user bent it.Furthermore, the tibial plate is indeed broken in two pieces, at the level of the tenth circular hole from the proximal side.The microscope inspection of the breakage surface show a shiny area, which proves that the two parts of the broken plate rubbed against each other for a while before the plate snapped completely (grey area corresponding to sudden fracture).Moreover, on the shiny area, "beach marks" features can be noticed clearly.This behavior is usually caracteristic to fatigue fractures.As a reminder, the ifu clearly states: "[.] ¿ 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.External immobilization (e.G.Bracing or casting) may be employed until x-rays or other procedures confirm adequate bone consolidation.[.]".The device inspection revealed the following: the plate's shaft is not flat as it is normally, but twisted around the longitudinal side of the plate.This bending of the plate is probably due to some torsional forces that were applied to the plate post-operatively, since no marks are visible on the plate surface that could lead to think that the user bent it.Furthermore, the tibial plate is indeed broken in two pieces, at the level of the tenth circular hole from the proximal side.The microscope inspection of the breakage surface show a shiny area, which proves that the two parts of the broken plate rubbed against each other for a while before the plate snapped completely (grey area corresponding to sudden fracture).Moreover, on the shiny area, "beach marks" features can be noticed clearly.This behavior is usually caracteristic to fatigue fractures.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 ANTEROLATERAL TIBIA PLATE AXSOS 3 TI FOR LEFT TIBIA 12 HOLE / L203MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8002668
• MDR Text Key: 124950566
• Report Number: 0008031020-2018-00892
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327081916
• UDI-Public: 07613327081916
• Combination Product (y/n): N
• PMA/PMN Number: K181091
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2018

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 627462
• Device Lot Number: V39021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Initial Date Manufacturer Received: 09/26/2018
• Initial Date FDA Received: 10/24/2018
• Supplement Dates Manufacturer Received: 11/15/2018
• Supplement Dates FDA Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 85