| Catalog Number |
03.010.405 |
| Medical Device Problem Code |
Device-Device Incompatibility (2919)
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| Health Effect - Clinical Code |
No Clinical Signs, Symptoms or Conditions (4582)
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| Date of Event |
09/14/2021
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Type of Reportable Event
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Malfunction
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Additional Manufacturer Narrative
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Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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 or Problem 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 the proximal femur fracture with the insertion handle and two aiming arms in question.During the surgery, when the surgeon drilled the distal lateral screw, the drill bit contacted.Procedure was completed successfully with thirty(30) minutes delay.Concomitant device reported: unk - screws: nail distal locking (part# unknown, lot# unknown, quantity unknown).Unk drill (part# unknown, lot# unknown, quantity unknown).Unk - drill bits: (part# unknown, lot# unknown, quantity unknown).This report is for one (1) radiolucent insertion handle f/trochanteric fixation nails.This is report 1 of 7 for complaint (b)(4).
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Additional 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.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 or Problem Description
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Patient was stable.
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Additional 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: part: 03.010.405 lot: 3537731 manufacturing site: werk hagendorf release to warehouse date: september 07, 2010 a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The product was returned to us customer quality (cq) for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that no defects were found with insert-handle radioluc f/pfna.The dimensional inspection was not performed for the insert-handle radioluc f/pfna due to complex geometry of the device.The functional test cannot be performed as all the mating device were not present.Both the aiming arms were mounted on the insertion handle and the parts were assembled as desired without any noticeable movement within the connection.The device cannot be tested for misalignment issue as the appropriate mating devices were not returned with the device.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for the insert-handle radioluc f/pfna.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.*********************************************** drawing/specifications reviewed the drawings reflecting the current and manufacture revision was reviewed.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.D1, d9 e3 h4.
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Search Alerts/Recalls
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