Model Number N/A |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
|
Patient Problem
No Patient Involvement (2645)
|
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
|
|
Event Description
|
It was reported that during internal inspection of product, the inner sterile packaging of an acetabular shell was found to be damaged.There was no patient involvement.
|
|
Manufacturer Narrative
|
(b)(4).Products have been returned to biomet uk ltd for evaluation and forwarded to the complaints and vigilance engineer who has reported as follows: the devices have been visually examined which has concluded that damage to the implant pouch has occurred.This is likely due to the fins breaking through the pouch, and as a result, compromising the secondary sterile barrier.A risk assessment using product sales verses complaints has been completed and has confirmed the risk has not been exceeded and therefore there is no risk to patient safety.A new revised packaging configuration was introduced to update the packaging of the mallory shell devices.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaints data base found no complaints for damaged packaging recorded for the new packaging configuration.It can be concluded that the devices returned in this evaluation were conforming to pre-defined packaging specification at the time of manufacture.Zimmer biomet will continue to monitor for trends.
|
|
Search Alerts/Recalls
|