Model Number N/A |
Device Problem
Mechanical Problem (1384)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Initial report: report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Medical product: oxf ant bone rmvl shaft-inner, catalog #: 32-423232, lot #: unknown multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00426.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported, that the spring jammed/stuck inside the anterior reamer shaft.The surgeon had to adjust to the stuck spring causing him to ream 1mm too far anteriorly.
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Event Description
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It was reported, that the spring jammed/stuck inside the anterior reamer shaft.The surgeon had to adjust to the stuck spring causing him to ream 1mm too far anteriorly.Another instrument was used to complete the surgery.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Gender : female, age :57, lot number : zb150701.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00426-1.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Manufacturer Narrative
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(b)(4).This final report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00426-2 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot number identification is necessary for review of device history records, it was provided.A review of the complaint database over the last 3 years has found 25 similar complaints reported with the item 32-423233 (including initiating complaint, and 27 similar complaints reported with the item 32-423233 (including initiating complaint, the outcome from hhed-2016-005 was that no hhe was required.Without the opportunity to examine the complaint product, a definitive root cause cannot be determined due to insufficient information.The most likely underlying cause is the contact between the two surfaces causing fretting and binding.No corrective or preventative actions are required at this time.If any additional information becomes available, then the complaint will be reopened and further investigated.
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Event Description
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It was reported, that the spring jammed/stuck inside the anterior reamer shaft.The surgeon had to adjust to the stuck spring causing him to ream 1mm too far anteriorly.Another instrument was used to complete the surgery.
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Search Alerts/Recalls
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