Zimmer biomet (b)(4).The device will not be returned for analysis as it was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00085.Medical products: sternalock 360 multi-implant system, part# 74-0004, lot# 066030.
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Upon further review, the root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device and therefore not reportable.The patient developed an infection and product was explanted approximately 5 1/2 months after implant.It was noted the patient had diabetes which is known to impact a patient's ability to heal and may contribute to development of an infection.During the investigation process a review of the sterile certifications were not reviewed for the unknown sternalock screw, as no product part/lot information was provided.All devices manufactured follow acceptable sterilization processes according to published iso/aami/astm & eu guidelines.As all product manufactured follow appropriate standards, and the reported infection occurred > 90 days, devices can be excluded as a possible source.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities such as risk factors.In this case, information received indicates the patient has diabetes which is a known risk factor which can lead to slow or impaired healing, and predisposition to infection.
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