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Model Number 292.72 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/23/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter is synthes sales representative.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that on (b)(6) 2019, during a repair of a tibial plateau, a patient was being treated with three (3) 4.5 mm cannulated screws.Approximately 1 cm of the threads of one the screws peeled off.Also, two (2) of the guide wires pulled out after drilling over them.The guide wires were inserted using a stryker drill and collet and it appears that the collet is scoring the guide wires.The scoring is sufficient to cause the guide wire to come out after drilling and removing the cannulated drill bit.The guide wires and drill bits were all new for the case.It is unknown if there was a surgical delay.Procedure outcome and patient status were unknown.Concomitant device reported: unknown stryker drill and collet (part # unknown, lot # unknown, quantity 1).Unknown drill bit (part # 310.65, lot # pe03478, quantity unknown).Unknown 4.5 mm cannulated screws (part # unknown, lot # unknown, quantity 2).This report is for one (1) 1.6 mm threaded guide wire 150 mm.This is report 3 of 5 for (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6- 1.6mm threaded guide wire 150mm was received.Upon visual inspection, it is observed that the device was bent.The threaded part was stripped and observed few wear marks on the surface of the device, during visual inspection under 10x magnification.Functional inspection cannot be performed because the alleged device was received by itself.This complaint is confirmed.But, the reported loose condition cannot be confirmed.Visual inspection, dimensional inspection, and document specification review of the received devices was performed.Thus, the complaint is confirmed.While a definitive root cause could not be determined, it is possible that the rough handling of the device might have contributed to the complaint condition.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Updated data-b5 device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that on (b)(6) 2019, during a repair of a tibial plateau, a patient was being treated with three (3) 4.5mm cannulated screws.Approximately 1 cm of the threads of one the screws peeled off.Also, two (2) of the guide wires pulled out after drilling over them.The guide wires were inserted using a stryker drill and collet and it appears that the collet is scoring the guide wires.The scoring is sufficient to cause the guide wire to come out after drilling and removing the cannulated drill bit.The guide wires and drill bits were all new for the case.It is unknown if there was a surgical delay.Procedure outcome and patient status were unknown.Concomitant device reported: unknown stryker drill and collet (part # unknown, lot # unknown, quantity 1).Unknown drill bit (part # 310.65, lot # pe03478, quantity unknown).Unknown 4.5mm cannulated screws (part # unknown, lot # unknown, quantity 2).
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Search Alerts/Recalls
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