MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR LEFT FEMUR 12 HOLE / L274MM; PLATE, FIXATION, BONE

Model Number	627612
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
It was reported the distal axsos 3 tibial plate fractured under patient load postoperatively.Revision surgery was performed.
Additional Manufacturer Narrative
D9 / h3 updated to indicate device was not returned the reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.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 the device is returned or if any additional information is provided, the investigation will be reopened and reassessed.H3 other text : device disposition is unknown.
Event or Problem Description
It was reported the distal axsos 3 tibial plate fractured under patient load postoperatively.Revision surgery was performed.
Additional Manufacturer Narrative
Please note corrections to section d9/h3; the device was returned and h6 (method and results codes).The reported event could be confirmed, since the plate is broken apart.The device inspection revealed the following: the visual inspection has shown that plate is broken apart at the 6th hole.The microscopic examination of the fracture surface reveals the fracture to be a typical fatigue fracture evident by a smooth topography.The origin of the crack was at the corner of the hole and there are lines of rest visible in this area.The instantaneous zone where the plate finally broke can also be identified.The relevant dimensions were verified during the investigation and no deviation from the specification could be detected.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.The plate was returned for evaluation and no product related issue could be detected.There was no additional information about the event provided, no x-rays and no information about the patient was available.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 from the instructions for use (non-active implant) can be pointed out: [these devices can break when subjected to the increased loading associated with delayed unions and/or non-unions.Internal fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing.If healing is delayed or does not occur, the appliance may eventually break due to metal fatigue.Loads on the device produced by load bearing and the patient¿s activity level will dictate the longevity of the device.]¿ [original statement] if more information is provided, the case will be reassessed.
Event or Problem Description
It was reported the distal axsos 3 tibial plate fractured under patient load postoperatively.Revision surgery was performed.

• Brand Name: DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR LEFT FEMUR 12 HOLE / L274MM
• Common Device Name: 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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12217495
• Report Number: 0008031020-2021-00316
• Device Sequence Number: 4172711
• Product Code: HRS
• UDI-Device Identifier: 07613252579588
• UDI-Public: 07613252579588
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2022

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 Model Number: 627612
• Device Catalogue Number: 627612
• Device Lot Number: G24103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 10/05/2021; 04/29/2022
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 11/01/2021; 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown