SYNTHES GMBH 1.5MM TI LOCKING SCR SLF-TPNG WITH T4 STARDRIVE RECESS 18MM; PLATE, FIXATION, BONE
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Catalog Number 04.214.018 |
Device Problems
Break (1069); Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/19/2021 |
Event Type
malfunction
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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 elbow arthroplasty procedure, the cortex screw and locking screw were broken and threads were peeled.The procedure was completed using another device.There was no patient consequence.There is no further information available.This report is for one (1) 1.5mm ti locking scr slf-tpng with t4 stardrive recess 18mm.This is report 2 of 2 for (b)(4).
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Manufacturer Narrative
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Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.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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Manufacturer Narrative
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Product complaint # (b)(4).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, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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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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.Visual inspection: the lockscr ø1.5 self-tap l18 tan was received at us cq.Visual inspection of the complaint device showed that only the head of the screw was returned.The head dimension and color were checked to confirm the screw family since the shaft was not returned.No peeling of the threads was observed.The attached photos were reviewed and no additional information was identified.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: no design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the screw had broken and only the head was returned.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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.Device history lot - 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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