An assessment of the returned device was carried out upon arrival.Very small scratches were observed on the lateral surface and one on the articulating surface.Evenly spaced small scratches were present on the shoulder of the articulating surface, possibly from a toothed instrument.No damage was found consistent with removal via guide pin piercing, and no significant damage to the implant was found.The height of the device was measured at 9.7 mm which is within the post-sterilization value range established through validation of the manufacturing process (9.0 mm - 10.3 mm).The device diameter was 10.2 mm, which is within the validated post-sterilization values (10.2 mm - 11.0 mm).The device weight recorded 0.8g, slightly under sterile devices weight range and possibly attributable to long-term compression.The slight mass loss likely did not impact device performance as the dimensions remained within the validated ranges.Based on the information received and the results of the investigation, a definitive root cause for this event could not be established.On november 10, 2020 stryker trauma and extremities acquired cartiva, wright medical, tornier inc.And tornier (b)(4).An effort was made to align the acquired entity complaint files with stryker's policies and procedures.Stryker has performed retrospective review of complaints and the reportability decision was revised to report this incident under the mdr/vigilance process.
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