MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW AXSOS 3 TI 5.0MM / L38MM; SCREW, FIXATION, BONE

Model Number	661138S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Injury (2348)
Date of Event	01/13/2020
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: "a patient who underwent a plate fixation procedure on (b)(6) 2019 complained of pain.When the x-ray was taken, the proximal part of the plate floated away from the bone.Then, on (b)(6) 2020, the plate was removed and fixed with k wires.".
Additional Manufacturer Narrative
The reported event could be confirmed based on the x-rays provided.Original statement from our medical expert: the x-rays shows a rorabeck type ii periprosthetic distal femur fracture.There are no pre-operative images available and only ap-view is depicted in the post- operative x-rays with the plate in place.The radiograph shows a persistent fracture gap direct post-op in the ap-view.The gap is probably 5mm and thus more than the cortical width of the bone at that height.There is no radiograph from the lateral and a gap can not be assessed, though.With poor bone quality as described by the clinic and diabetes (which also leads to reduced metabolism) this may have contributed to the non-union and consequently dislocation of the plate.The initial reduction is not ideal from what the picture demonstrates.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.Based on investigation, the root cause was attributed to be patient related.The failure was caused by non-union and consequently resulted of the dislocation of the plate (screws were still locked in place though).If any further information is provided, the investigation report will be updated.
Event or Problem Description
As reported: "a patient who underwent a plate fixation procedure on (b)(6) 2019 complained of pain.When the x-ray was taken, the proximal part of the plate floated away from the bone.Then, on (b)(6) 2020, the plate was removed and fixed with k wires.".

• Brand Name: LOCKING SCREW AXSOS 3 TI 5.0MM / L38MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9742083
• Report Number: 0008031020-2020-00501
• Device Sequence Number: 1815212
• Product Code: HWC
• UDI-Device Identifier: 04546540686138
• UDI-Public: 04546540686138
• Combination Product (Y/N): N
• 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): 03/20/2020

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: 04/30/2023
• Device Model Number: 661138S
• Device Catalogue Number: 661138S
• Device Lot Number: Y18594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 03/20/2020
• 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: 81 YR