Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 12/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.The surgeon reported two possible part numbers 45-2010 or 45-2012.He thought it was 45-2012 but he was not certain.Part#: 45-2010.Brand name: traumaone system 2.0x10mm cross-drive screw, 5pk.Catalog number: 45-2010.Udi number: (b)(4).Part#: 45-2012 brand name: traumaone system 2.0x12mm cross-drive screw, 5pk.Catalog number: 45-2012.Udi number: (b)(4).The user facility is foreign; therefore, a facility medwatch report will not be available.Report source: (b)(6).
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Event Description
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It was reported the screw fractured and the screw body remained in the patient during a maxillofacial surgery.The pilot hole was drilled to a specific depth prior to the insertion attempt.The screw was seated flush with the plate and fractured on the final turn when tightening.The head of the screw sheared off the body of the screw.No additional patient consequences were reported.
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Event Description
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It was reported the screw fractured and the screw body remained in the patient during a maxillofacial surgery.The pilot hole was drilled to a specific depth prior to the insertion attempt.The screw was seated flush with the plate and fractured on the final turn when tightening.The head of the screw sheared off the body of the screw.Only three (3) screws were able to be placed instead of four (4), which was described as not ideal in a fracture that requires two (2) screws on either side of the fracture.No additional patient consequences were reported.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.This report is being submitted to update additional information in section b5, d1, d4, h6 and h10.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.A visual inspection was conducted on the returned screw.The screw has fractured where the screw head meets the screw shaft.A dimensional analysis was unable to be conducted due to the damage to the screw.The complaint is confirmed.A determination cannot be made as to what caused the screw to fracture.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot be determined.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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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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