MAUDE Adverse Event Report: STRYKER GMBH LOCKING COMPRESSION PLATE BROAD AXSOS 3 16 HOLE / L299MM 5.0MM LOCKING; PLATE, FIXATION, BONE

Model Number	627576S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "the surgeon removed a broken axsos plate on (b)(6) 2022.Plate had been recovered.Plate was sterile packed and implanted on (b)(6) 2022.The surgeon reported the patient stating she had been walking 2 miles a day.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "the surgeon removed a broken axsos plate on (b)(6) 2022.Plate had been recovered.Plate was sterile packed and implanted on (b)(6) 2022.The surgeon reported the patient stating she had been walking 2 miles a day.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the plate is broken as complained.The device inspection revealed the following: the visual inspection has shown that the plate is broken apart on the fourth locking hole.The breakage of the plate can also be confirmed on the received x-rays.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 upper right corner of the locking hole and there are progression lines in this area visible.The rest of the fracture face has the typical view of a fatigue fracture with an uniform fine-grained texture.The relevant dimensions were as far as possible checked 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 complaint was forwarded to medical affairs for a medical opinion with following feedback: "no obvious technical failures can be seen.There are some patient related factors which assumingly have contributed to the failure of the plate.First of all the patients age.At that age the bone quality and the capability of restoration of bone is definitely reduced.Then we have ¿kissing¿ prostheses of the hip and (stem) of the knee joint.The ¿working range¿ of the bone is only a few centimeters.Instead of distributing the load on the whole plate - due to the stiff hip and knee joint stem - movement and thus energy transfer is only possible at the short bone area in between the prostheses.This is probably the most relevant factor, here.I would recommend to add a second plate at the medial circumference of the femur to exclude high loads on the plate.I fear that although additional measurements have been taken with the cerclage the outcome (breakage) may become the same." based on investigation, the root cause of the breakage was attributed to a patient related issue.Different patient related factors did result in fatigue failure of the plate.If more information is provided, the case will be reassessed.

• Brand Name: LOCKING COMPRESSION PLATE BROAD AXSOS 3 16 HOLE / L299MM 5.0MM LOCKING
• 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: 15112466
• Report Number: 0008031020-2022-00364
• Device Sequence Number: 5589479
• Product Code: HRS
• UDI-Device Identifier: 07613327135138
• UDI-Public: 07613327135138
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2022

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 Expiration Date: 01/31/2025
• Device Model Number: 627576S
• Device Catalogue Number: 627576S
• Device Lot Number: D61662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2020
• 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: Female