Catalog Number 314.116 |
Device Problem
Scratched Material (3020)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/15/2022 |
Event Type
Injury
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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 an unknown date in (b)(6) 2015, the patient underwent the surgery with a philos implants.The surgery was completed successfully without any surgical delay.After the surgery, removal surgery was performed on (b)(6) 2022, due to unknown reason.In the removal surgery, it was difficult to remove the locking screw and chipped the tip of the screwdriver shaft.The second screwdriver was used, but this tip was also chipped.The locking screw was removed using a vice grip.The removal surgery was completed successfully without any surgical delay.It is not known if fragments were removed or not.This is report 2 of 3 for (b)(4).This report is for a screwdriver shaft.
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Manufacturer Narrative
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Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is j&j company representative.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 history: part # 314.116, synthes lot # 7525402, supplier lot # n/a, release to warehouse date: 28 feb 2014, manufacturing location: (b)(4).No ncr's were generated during production.No code available is for injury; it is not known if fragments remained behind in the patient.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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The initial complaint was reviewed and found not reportable.Upon review of this product complaint it was identified that the reported information reasonably suggest that this product may not have caused or contributed to a serious injury.
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Search Alerts/Recalls
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