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

Model Number	627644
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561)
Date of Event	01/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that a t2 alpha retrograde and axsos distal lateral femur plate failed resulting in a revision.
Additional Manufacturer Narrative
Please note the correction to d9/h3 as the device was not returned for evaluation.The reported event was not confirmed on provided x-ray copies; the referenced plate appeared not to be broken ¿ neither was a deficiency alleged.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 was not performed since referenced plate appeared not to be broken ¿ neither was a deficiency alleged.No indications of material, manufacturing or design related problems were found during the investigation.In the case presented a 59 year-old male patient; 173 cm / 81 kg had initially been treated with a t2alpha retrograde nail which broke after approx.1 year of implantation.Simultaneously above plate had been implanted with the nail.Provided x-ray copies were sent to a health care practitioner for review.His comments in extracts: ¿the available x-ray copies revealed non-union after an implantation period of approx.1 year.A radiological metaphyseal gap of 2-3 cm, at the level of the broken locking screw hole, initially causing micro movements, and resulting in hypertrophic/partly atrophic non-union is a likely outcome.A nail, firmly connected to the implanted plate, could neither be confirmed nor excluded.¿ as no rigid connection between nail and plate was proved the use of nail and plate for the same indication could not be named off-label-use.Based on investigation, the root cause was attributed to a patient related issue.The nail failure was caused by inappropriate bone healing contributed by suboptimal placement of the nail implant.The plate did not present a failure.H3 other text : device disposition unknown.
Event or Problem Description
It was reported that a t2 alpha retrograde and axsos distal lateral femur plate failed resulting in a revision.

• Brand Name: DISTAL LATERAL FEMUR PLATE AXSOS 3 FOR RIGHT FEMUR 14 HOLE / L310MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16294258
• Report Number: 0008031020-2023-00045
• Device Sequence Number: 6522982
• Product Code: HRS
• UDI-Device Identifier: 07613252579687
• UDI-Public: 07613252579687
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K200398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2023

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: 627644
• Device Catalogue Number: 627644
• Device Lot Number: G30988
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2020
• 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 Age: 58 YR
• Patient Sex: Male
• Patient Weight: 81 KG