Model Number N/A |
Device Problems
Failure To Adhere Or Bond (1031); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Code Available (3191)
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Event Date 06/16/2017 |
Event Type
Injury
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Manufacturer Narrative
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Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
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Event Description
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It is reported the surgeon had a few wires and had the sternalock 360 implants in at the manubrium and body of the sternum.When finalizing the last plate the band would not pass through because the slot was solid (not machined out).The surgeon wanted to use the proper construct as recommended, however there was only one implant kit present at the time.The surgeon opted to remove the sternalock 360 implants and complete the procedure using wires (non-zimmer biomet product).There was a four minute surgical delay and no injury to the patient.
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Manufacturer Narrative
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A visual inspection of the returned product found that only one band was returned with no original packaging.Removing the part from the bag and inspecting it can be seen that the band window on the locking mechanism body is only half way machined through and the finger slot where the cam slides into lock is missing from the body.These missing features will cause the part to be un-usable; therefore the complaint is confirmed.The most likely cause of the band window being missing is due to the tooling breaking during machining, and this piece being missed during the machine operators inspection of the parts ran with a broken tool.The device history record was reviewed and no deviations were identified.
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Search Alerts/Recalls
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