Catalog Number 253106000 |
Device Problems
Naturally Worn (2988); Scratched Material (3020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint #: (b)(4).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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Event Description
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Complaint is related to (b)(4).This complaint was created due to the excess impacted products in (b)(4).Damaged plastic femoral head trials - need replacement.Plastic is worn and scratched on head trials.
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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary: according to the information received, "damaged plastic femoral head trials - need replacement" the product was not returned to depuy synthes, however photos were provided for review.See attachment a-10190341 (b)(4)source data.The photo investigation revealed that 12/14 articul 40mm trial +5 presents several scratches all over the outer surface.Additionally, the device exbibits an overall worn condition, consistent with repeated use and servicing.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.Regarding the scratches, this type of damage is consistent with other tools and hard edges coming in contact with the device, properly handling and attention to the approved use of the device diminishes the risk of failure.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the 12/14 articul 40mm trial +5 would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to unintended use error 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 : a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code dpg0907 provided is not a valid finished goods lot#.
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Event Description
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Additional information received: a.What was specifically the damage on the devices (broken (2+ pieces), cracked, bent, stripped/worn).Plastic is worn and scratched on head trials.B.Can you please provide the lot no of the reported products? working with ops to swap out, lot numbers will.Be available on return of trial heads c.What is the event date? as reported by the pc- heads have been worn over time with use.D.Was/were there any adverse consequence/s that affected the patient because of the reported event? no.E.Did the event occur during the surgery? if yes, was there a surgical delay? what is the duration of the delay? no, identified outside surgery.
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Search Alerts/Recalls
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