Model Number N/A |
Device Problem
Fracture (1260)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 07/13/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Zimmer biomet complaint (b)(4).Lot number: based upon a review of inventory transactions and the customer's purchase history, there are seven possible lots: 967110, 712490, 128660, 491690, 067270, 588360, 790210.Unique identifier (udi) number: (b)(4).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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00860.
|
|
Event Description
|
It was reported the top of the benders broke during surgery.Attempts have been made and no further information has been provided.No adverse events have been reported as a result of the malfunction.
|
|
Event Description
|
This follow-up report is being submitted to relay additional information.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.No product was returned and no functional tests or inspections could be performed.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The bender showed signs of significant use with scratches and fading of the lettering apparent.Functional testing was attempted by attempting to bend a pectus bar.When attempting to do so, the opposing leaf springs would deflect upwards and the bar would not bend.Manufacturing history was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to plastic deformation of the leaf springs sustained over the lifetime of the product.A summary of the investigation has been sent to the complainant.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00860-2.
|
|
Event Description
|
This follow-up report is being submitted to relay additional information.
|
|
Search Alerts/Recalls
|