Model Number N/A |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
|
Event Date 04/07/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Foreign report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.(b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
Upon opening the sterile packaging of ceramic heads, it was reported that the foam packaging stuck to the tyvek lid.This device was used on this surgery.
|
|
Manufacturer Narrative
|
(b)(4).This final report is being submitted to relay additional information.G3: report source, foreign - event occurred in japan.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.We have not been provided with or any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaints database over the last 3 years has found no similar complaints for this item code.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: relevant line: - 5.1.2 ¿ customer cannot deliver product into the sterile field in a controlled manor.The severity score associated with this failure mode is 2 (temporary or reversible impairment (without medical intervention)) with an occurrence score of 1 (<1 in 10000).Severity assessment: -this event occurred during surgery.No further information has been provided/no harm was reported/a non-clinically significant delay (<30mins) to surgery was reported.-the severity score is in line with the risk file.Corrective and preventive actions taken: ca-03419/ ie-11839 has been raised to investigate this issue.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.H3 other text : product remains implanted.
|
|
Event Description
|
Upon opening the sterile packaging of ceramic heads, it was reported that the foam packaging stuck to the tyvek lid.This device was used on this surgery.No patient, user, or other stakeholder harm.
|
|
Search Alerts/Recalls
|