MAUDE Adverse Event Report: STRYKER GMBH DISTAL MEDIAL TIBIA PLATE AXSOS 3 TI FOR RIGHT TIBIA 14 HOLE / L227MM; PLATE, FIXATION, BONE

Model Number	627444
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	03/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The doctor reported that: " fracture of orthopaedic material 2 and a half months after fitting".Additionally reported: "removal of material"."secondary displacement"."amos + tibial nail placement".
Event or Problem Description
The doctor reported, that "fracture of orthopaedic material.2 and a half months after fitting".Additionally reported: "removal of material", "secondary displacement", "amos + tibial nail placement".
Additional Manufacturer Narrative
Correction: refer to h6 patient code.The reported event, that distal medial tibia plate axsos 3 ti, for right tibia 14 hole / l227mm was alleged of issue ¿implant breakage post-operative¿ could be confirmed.Since the device was returned for evaluation and matches the reported failure mode.As per the visual inspection, the received device was found to be broken around the central region at the 5th hole from proximal side.The microscopic images indicate, this to be a fatigue fracture.Fatigue fractures occur under repeated or fluctuating stresses.The maximum stress in a part is less than the yield strength of the material.Fatigue fractures begin as a microscopic crack or cracks that grow as force is applied repeatedly to a part.When the load is high, the number of required cycles for the part to finally break is low.Fatigue fractures don¿t require high stress, so there is usually very little deformation.A review of the device history for the reported lot, did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found, during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation, the root cause of the failure is predominantly patient factor related as he was moderately active post implantation.And the rationale is also supported by the labeling "the axsos plating system is not intended to transmit full forces and bending moments of daily routine.Especially in the lower extremity loading and weight bearing have to be individually reduced.Depending on these individual influencing factors.The attending physician has to determine the maximum loading.And has to limit the weight bearing respectively.In the case of an overloading or due to poor implantation technique an implant failure may result".If any additional information is provided, the investigation will be reassessed.

• Brand Name: DISTAL MEDIAL TIBIA PLATE AXSOS 3 TI FOR RIGHT TIBIA 14 HOLE / L227MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9954995
• Report Number: 0008031020-2020-01277
• Device Sequence Number: 19535041
• Product Code: HRS
• UDI-Device Identifier: 07613327082685
• UDI-Public: 07613327082685
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K181091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/30/2023
• Device Model Number: 627444
• Device Catalogue Number: 627444
• Device Lot Number: Y49806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR