Catalog Number 254500736 |
Device Problem
Scratched Material (3020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/07/2024 |
Event Type
malfunction
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Event Description
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It was reported that the femoral trials had significant scratches/gouges.Mainly size 6 and 7 trials.Can this please be looked at or swapped out.It was from a loan tray (znauk0817) was surgery delayed due to the reported event? no, was procedure successfully completed? yes, were fragments generated? no, if yes, were they removed easily without additional intervention? unknown, patient status/ outcome / consequences no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: no, is the patient part of a clinical study no, (b)(4) device property of none, device in possession of none, (b)(4) device property of none, device in possession of none, (b)(4) device property of none, device in possession of none by checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.
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Manufacturer Narrative
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Product complaint (b)(4) investigation summary according to the information received, "[ several of the femoral trials had significant scratches/gouges.Mainly size 6 and 7 trials." the product was not returned to depuy synthes, however photos were provided for review.See attachment (re pc (b)(4) (b)(6) hosp request for additional information - 1st attempt,.The photo investigation revealed that the device 254500736, attune ps fem trial sz 6 lt had broken chips and scratched on the surface, cracked on the middle of the surface.Potential cause for crack condition : the potential cause is traced to repeated impaction forces during trailing in combination with the trial fitting very tightly posteriorly/anteriorly over the resected femur bone.This will cause tensile stress initiating at the bone contact surface in the middle of the trial between the condyles, resulting in material fatigue and ultimately cracking.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.Potential cause for broken and scratch condition : this type of damage is consistent with the device coming in contact with the saw blade while trailing, care should be taken to avoid saw blade excursion into the femoral trials or implants.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the 254500736, attune ps fem trial sz 6 lt would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to end of life problem identified for cracked condition and potential cause can be attributed to unintended use error for scratched, broken condition and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Search Alerts/Recalls
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