This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Review of the device history record for 00515048200, lot number z000008400, identified no relevant deviations or anomalies.Product examination found that the unit had ruptured inside the sealed sterile packaging.This complaint is confirmed.Product examination found that the sealed unit had ruptured before it had been opened.While rare, this kind of event occurs when the batteries overheat from a short circuit.To address this issue, change notice has been implemented to adjust the length of the wires inside the battery pack.This means that there will no longer be a need to tightly fold wires inside the battery pack in order for them to reach their respective circuit contacts.This reduces the risk of a short circuit.The root cause of the reported event is that the battery ruptured due to a short circuit.The cause of this cannot be specifically determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.
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