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

Model Number	627614
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/09/2020
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
As reported: "axsos 3 distal femur left 14 hole plate broke at a screw hole.Needed a revision surgery.".
Additional Manufacturer Narrative
Corrections: please refer to section d4 (catalog number and gtin).The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the plate is broken in half and both pieces were received for inspection.The breakage point is located along the 4th shaft hole (counting from the big rounded plate end).The surface of the plate shows marks of usage - scratches and a few dents - most likely caused during explantation.The surface breakage of the axsos plate shows that the material of one of the two bridges is shiny, which proves that the device most likely broke at that level first.That first breakage was most probably due to repetitive patient activity.After the first bridge breakage, the two sides of the plate rubbed against each other for some cycles before the second bridge broke too.The surface of the second bridge shows a matte grain of the material, which proves that the material broke at once (sudden fracture of the material), again because of application of high forces to the material.This behavior is usually characteristic 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.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿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 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 post-operative examinations (e.G.X-ray checks) are advisable.Implant removal should be followed by adequate post-operative management to avoid fracture or refracture of the bone.The surgeon must warn the patient that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity, trauma, mal-union or non-union and that the device has a finite expected service life and may need to be removed at some time in the future.Adverse effects: 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.Conditions attributable to non-union, osteoporosis, osteomalicia, diabetes, inhibited revascularization and poor bone formation can cause loosening, bending, cracking, fracture of the device or premature loss of rigid fixation with the bone.¿ formal medical opinion was sought from an experienced independent medical expert as below; ¿this has been analyzed by the surgeon already.Knowing, that the plate alone would fail it would have been wise to use a neutralization plate in an ap-direction.However, the initial construct was okay, but it is also true, that the working length of the plate was a little bit too long and it would have been better to use at least one hole closer to the fracture site proximal and distal.Regarding the mobilization: this is not presented detailed enough and it is also dependent on the weight of the patient.It is very likely, though that patient¿s bone is osteoporotic/ osteopenic.The probable root cause of the plate breakage is overload to the plate with insufficient bone healing and biological support.¿ based on investigation, the root cause was attributed to a patient factor related issue.The failure was caused by overload to the plate with insufficient bone healing and biological support.The device inspection confirms that material broke because of application of high forces to the material.This behavior is usually characteristic to fatigue fractures.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "axsos 3 distal femur left 14 hole plate broke at a screw hole.Needed a revision surgery.".

• Brand Name: DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR RIGHT FEMUR 14 HOLE / L310MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11121139
• Report Number: 0008031020-2021-00001
• Device Sequence Number: 19731818
• Product Code: HRS
• UDI-Device Identifier: 07613252579595
• UDI-Public: 07613252579595
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K200398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

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: 627614
• Device Catalogue Number: 627644
• Device Lot Number: J36985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 04/23/2021
• 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