|
Model Number N/A |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 05/22/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Report source: foreign: country: (b)(4).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: 0001825034-2020-02186, 0001825034-2020-02187, 0001825034-2020-02188, 0001825034-2020-02190, 0001825034-2020-02191.
|
|
Event Description
|
It was reported circulated items were investigated and identified debris in sterile packages.No patients were involved.No additional information.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Evaluation of the returned product/photographs provided confirmed the following: lot #3873650; 3595073: debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier.Lot #3669984, 3684079, 3387034, 3572245: debris inside the sterile packaging which is consistent with the appearance of the porous coating and foam debris from the foam packaging inside the sterile barrier.The reported event is confirmed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The likely condition of the product when it left zimmer biomet was conforming to specification.The root cause of the reported event is likely to be due to transit damage.A corrective action has been initiated to address the reported event.As a result, the pouch is being improved to use a stronger material (nylon), and foam end caps are being added.Also, the orientation the devices are packed in the shipper box is moving from vertical to horizontal, and the thickness of the shipper box has been increased.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.
|
|
Event Description
|
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.
|
|
Search Alerts/Recalls
|
|
|