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Model Number N/A |
Device Problem
Expulsion (2933)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/13/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation because it has been discarded as biohazard.However, the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Hospital discarded as biohazard.
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Event Description
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It was reported that during surgery, the product's battery pack has exploded during use.No adverse events have been reported as a result of the malfunction.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).Investigation summary: review of the device history record for 00515048201, lot number z000005979, identified no relevant deviations or anomalies.Product examination could not be performed as no product was returned for this complaint.This complaint cannot be 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 (b)(4) 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 could not be specifically determined with the provided information.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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Search Alerts/Recalls
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