This event has been recorded by zimmer biomet under (b)(4).Investigation summary: review of the device history record for 00515048200, lot number z000007533, identified no relevant deviations or anomalies.Product examination could not be performed as no product was returned for this complaint.However, the customer provided photos that show the battery pack had ruptured from overheating batteries inside the sealed sterile packaging.This complaint is confirmed.The reported event claimed 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 cn 22170 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 cannot be specifically determined with the provided information, as no product was returned for this complaint and the photographic evidence does not make it clear how the failure occurred.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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