ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN, DISTAL PART, CURVED, UNCEMENTED, 16/200; HIP PROSTHESIS
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Model Number N/A |
Device Problems
Tear, Rip or Hole in Device Packaging (2385); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/27/2021 |
Event Type
malfunction
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Event Description
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It was reported, that: when opening the box, the implant packaging was perforated.The product has not been implanted.
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Manufacturer Narrative
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This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states.The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional and/or corrected information.Investigation and conclusion: event description: it was reported,that: when opening the box, the implant packaging was perforated.Harm: s1 - no patient, user, or other stakeholder harm hazardous situation: packaging: device not used for implantation due to primary packaging damage.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Images: review of the received images show that the inner packaging (sterile bag) is perforated.Product evaluation: visual examination: the visual examination shows that in all 3 layers of the bags (ivp, avp, svp) there is a rip exactly at the area where the bags were folded.Further, no conspicuousness could be identified.The outer cardboard box was not returned.Based on this visual examination the reported event can be confirmed.Review of product documentation: device purpose: this device is intended for treatment.Conclusion: it was reported that during surgery the packaging of the implant was perforated.The surgery was completed with another implant with a smaller diameter.Based on the investigation the reported event can be confirmed.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Furthermore, the outer packaging (product packaging) was found slightly damaged and deformed.Therefore it can be concluded that a wrong handling or transportation issue of the device has most likely led to the damaged packaging.However, a big scope of packaging configurations was changed in the year 2017.In the meanwhile a optimized packaging design is available.With this change of the packaging design, this kind of incident (perforation of the sterile bag) has been eliminated.Furthermore, there are no other complaints for this item number nor for the same lot number.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.However, the most likely root cause for the reported error pattern is damage during transport/storage.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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Investigation results are available.
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Search Alerts/Recalls
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