Upon inserting the cup, surgeon connected the alignment guide onto the cup holder.While impacting the cup holder, the screw on the alignment guide broke and fell into the wound.Surgeon managed to remove the screw from the wound, however, the black rubber bump that came with the screw was unable to find.
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This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states.The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.It was reported that while impacting the cup, the screw on the positioning guide broke and fell into the wound.The screw could be removed, however, the black rubber bump could not be found.The visual examination of the returned device confirms that the m4 screw is broken.The fracture is right next to the knob and the black o-ring is missing.No deviations and/or anomalies were discovered during manufacturing that may have affected the surgical outcome or contributed to the reported event.Therefore, it is not expected that the manufacturing process contributed to the reported issue.Device is used for treatment.The o-ring is a necessary component to ensure the mechanical function of the lateral positioning guide.The investigation did not identify a definite cause for the screw breakage that led to the disassembly of the o-ring.The reported event can be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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