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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 07/20/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).Additional narrative: this report is for an unk - nails: pena/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.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 open reduction internal fixation surgery for trochanteric femur fracture.During the surgery, pfna was implanted, and the drill bit came into contact with the nail and the distal locking screw could not be inserted well.The surgeon handled the drill bit but could not insert the locking screw.There was an axial deviation between the nail and the sleeve.The surgery was completed without inserting the locking screw.The surgery was completed successfully within 30 minutes delay.No further information is available.This complaint involves one (1) device.This report is for (1) unk - nails: pfna.This report is 2 of 4 for (b)(4).
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Search Alerts/Recalls
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