WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.2MM DRILL BIT/QC/145MM; INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH
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Model Number 310.31 |
Device Problems
Break (1069); Entrapment of Device (1212)
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Patient Problems
Injury (2348); Foreign Body In Patient (2687)
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Event Date 10/18/2020 |
Event Type
Injury
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Manufacturer Narrative
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Additional procode: gff, gfa, hsz.Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j employee.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) 2020 during orif distal femur procedure, the drill bit broke while drilling.The surgeon was hitting a lot of metal and bone cement.The tip of the drill bit was left in the patient.There was no surgical delay.The procedure was successfully completed.Patient outcome was unknown.This report is for one (1) 3.2mm drill bit/qc/145mm.This is report 1 of 1 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.B5: additional event description updated.H6: codes updated.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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Additional event description.Concomitant device reported: unknown bone cement (part #: unknown, lot #: unknown, quantity: 1).
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