Model Number N/A |
Device Problems
Fracture (1260); Unstable (1667)
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Patient Problem
No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).Report source: foreign country - (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.
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Event Description
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It was reported that a rapidflap lb cranioplasty was performed, and at the time of starting to lower one of the cymbals of the system, the pole was split between the two cymbals.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The complaint is that the clamps kept turning and did not achieve fixation.The distributor reported that the clamps remained implanted.No product was returned and no functional tests or inspections could be performed.For these reasons, the complaint could not be verified and the most likely underlying cause of the complaint could not be determined.There are no indications of manufacturing defects.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.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The lactosorb rapidflap clamp (part #915-0020, lot #unknown) was visually inspected.The post was found to be fractured in two places.The majority of the post was left in tact in the applier, while a short section broke off and was stuck inside the outer plate, which indicates the post broke while the outer plate was being threaded down into position on the post.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Investigation results concluded that the reported event was due to excessive force while screwing the outer plate onto the post.The instructions for use (ifu) for this product states in the section titled warnings: improper selection, placement, positioning, or fixation of the implant can cause a subsequent undesirable result.The surgeon is to be familiar with the device, the method of application and the surgical procedure prior to performing surgery.The devices can break or be damaged due to excessive activity, load bearing upon insertion in vivo, or trauma.This could lead to failure of the device, which could require additional surgery and/or device removal.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.
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Event Description
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Additional information was provided.The distributor reported "we returned only one that was the one that was removed because it broke and we returned it for study, the other two the specialist left implanted despite being loose.".
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Additional event details were provided on may 8, 2018.
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Search Alerts/Recalls
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