(b)(4).Concomitant medical products: tprlc xr t1 pps 13x146mm mm t1 cat# 51-105130 lot# 3564650, tprlc xr t1 pps 12x144mm mm t1 cat# 51-105120 lot# 3560787, tprlc 133 t1 pps so 16x152mm t1 cat# 51-103160 lot# 3581704, tprlc 133 t1 pps ho 17x154mm 4mm t1 cat# 51-104170 lot# 2457955, tprlc 133 t1 pps ho 16x152mm 2mm t1 cat# 51-104160 lot# 2548615.(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01520, 0001825034-2020-01522, 0001825034-2020-01523, 0001825034-2020-01524, 0001825034-2020-01525.
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This follow-up report is being submitted to relay additional information.Evaluation of the returned product confirmed the event.Visual inspection confirmed white debris within the sterile packaging.The insert has been damaged such that particles have become detached and float freely within the sterile packaging.The blister seal remains intact.The outer packaging is roughened through handling but no notable damage was observed.Review of the device history records for the reported items identified no deviations or anomalies related to the reported issue during manufacturing.The root cause of the reported event is likely to be due to transit damage causing the foam packaging to become abraded and shed and/or the porous coating to shed from the implant.A corrective action has been initiated to address the reported event.Upon investigation, it has been determined that the debris in the sterile packaging meets the acceptable criteria and product is conforming to specifications.Event is no longer considered reportable, and initial report should be voided.
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