(b)(4).Concomitant medical products: tprlc 133 t1 pps ho 13x146mm 6mm t1 cat# 51-104130 lot# 3711469, tprlc 133 t1 pps ho 11x142mm 2mm t1 cat# 51-104110 lot# 3765796, tprlc 133 t1 pps ho 16x152mm 2mm t1 cat# 51-104160 lot# 3458649, tprlc 133 t1 pps ho 16x152mm 2mm t1 cat# 51-104160 lot# 2469061, tprlc 133 t1 pps ho 11x142mm 2mm t1 cat# 51-104110 lot# 3677485.(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: 0001825034-2020-01535, 0001825034-2020-01536, 0001825034-2020-01537, 0001825034-2020-01538, 0001825034-2020-01540.
|
This follow-up report is being submitted to relay additional information.The complaint sample was evaluated and the reported event was confirmed through visual inspection.The returned packages showed white debris within the sterile packaging.The inserts were damaged such that particles had become detached to float freely within the sterile packaging.The debris was consistent with the foam packaging inside the sterile barrier.The blister seal remained intact and the outer package appeared roughened through handling with no noticeable damage.The device history records were reviewed and no discrepancies were identified.The likely condition of the product when it left zimmer biomet was conforming to specification.Therefore, the root cause of the reported event is likely to be due to transit damage causing the foam packaging to become abraded and shed.The device evaluation found no malfunction and the event did not contribute to injury, therefore this would not be considered a reportable event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|