SYNTHES GMBH TI END CAP FOR TFNA 0MM EXTN - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number 04.038.000S |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Additional narrative: 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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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent the osteosynthesis for the trochanteric femur fracture with the endcap in question.During the surgery, the surgeon couldn¿t insert the endcap.Procedure was completed successfully with thirty(30) minutes delay without inserting the endcap.Concomitant devices reported: unk - screwdrivers(part# unknown, lot# unknown, qty unknown).This report is for one (1) ti end cap for tfna 0mm extn - sterile.This is report 1 of 1 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: 04.038.000s lot: 91p7057, manufacturing site: bettlach, release to warehouse date: 03 march 2021, expiry date: 01 february 2031.A manufacturing record evaluation was performed for the finished good 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.
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Search Alerts/Recalls
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