Referring to the product inquiry the femoral nail, right t2 gtn ø10x380 mm is the only reported device and thus considered the primary product.The nail reported remains implanted.The issue is about an exceeded expiry date and physical examination is not required.Review of the device history records of the nail reported did not indicate any conspicuity.The dhr contain a copy of the label set (label for packaging and patient record label); all labels indicate end of shelf life by feb 29, 2016 (nominal value).The device reported was documented faultless prior to distribution.In the case presented a t2 greater trochanter nail (t2 gtn) was implanted whose sterilization date was exceeded by 42 days (expiration date: 02/29/2016; date of implantation: (b)(6) 2016).Real aging tests performed with stryker implants in 2007 reveal that there is a safety tolerance; implants with exceeded expiry date were checked more than 1 year overdue and considered still sterile subsequently.Thus, in this specific case of exceeded expiry date by 42 days a risk for the patient is not to be expected.A consultant hcp stated in a similar case that a risk for the patient is not to be expected although an expired nail had been implanted.The expiry date is a theoretical date, which offers a high level of safety and the risk of an infection caused by a simple transgression of the expiry date is negligible.Nevertheless, the expiry date of the reported nail kit should have been noticed prior to surgery as it is always to be noticed on the label; according to the sales rep the implant was hospital-owned at the time of implantation.Evaluation revealed evidence that the event is not linked to a deficiency of the device but is rather related to misuse; the root cause of the event is in the field of responsibility of the user.No non-conformity in terms of product quality was identified.
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