SYNTHES GMBH 3.5MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 40MM; ROD,FIXATION,INTRAMEDULLARY
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Catalog Number 412.117 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Additional procode: ktt.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 during an unknown procedure, the 3.5mm locking screw had apparent wear on the screw head.The implant was not used in the procedure but it was noted it arrived in this condition.There is no further information available.This report is for one (1) 3.5mm ti locking scr slf-tpng with stardrive recess 40mm.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.H6: a device history record (dhr) review was conducted: part: 412.117, lot: l556603, manufacturing site: grenchen, release to warehouse date: 31 august 2017.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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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