SYNTHES PRODUKTIONS GMBH 4.5 TI MULTILOC SCREW LENGTH 22-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number 04.019.022S |
Device Problems
Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/23/2021 |
Event Type
Injury
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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) 2021, patient underwent a surgical procedure, while inserting an interlocking multliloc screw, the screw was too short.The surgeon continued to try to insert the multiloc screw possible stripping out the plastic insert of the multiloc humeral nail.The screw was pulled out of the bone and nail, and abandoned that screw hole procedure was completed successfully with a five(5) minutes surgical delay.No patient consequence reported.Concomitant device reported: unk - insertion instruments: trauma (part # unknown; lot # unknown; quantity: 1).This report is for one (1) 4.5 ti multiloc screw length 22-sterile.This is report 2 of 2 for complaint (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: part: 04.019.022s-us.Lot: l962462.Manufacturing site: grenchen.Release to warehouse date: 06 july 2018.Expiration date: 01 june 2028.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Product was not returned.Based on the information available, it has been determined that no corrective and 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.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.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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Search Alerts/Recalls
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