Catalog Number 257005100 |
Device Problems
Device-Device Incompatibility (2919); Naturally Worn (2988)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/12/2023 |
Event Type
malfunction
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Event Description
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Summit standard imp.Inserter has a damaged tip and is getting stuck in prosthesis.Instrument tagged as damaged.No harm to pt.No delay.Was surgery delayed due to the reported event?: no.If yes, number of minutes: 0.Was procedure successfully completed? yes.Were fragments generated? no.If yes, were they removed easily without additional intervention? no.Patient status/ outcome / consequences: no.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Is the patient part of a clinical study? unknown.(b)(6).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).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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Additional information received that the tip of this instrument is a very specific shape and it sits into the top of the real prosthesis for impaction.The damage i am referring to is that this instrument is misshaped and no longer fits into the prosthesis.I guess ¿worn¿ is the best descriptor for it.
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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.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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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Manufacturer Narrative
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Product complaint # : (b)(4).Investigation summary : according to the information received, "consignment corail stem introduced has a damaged tip and is getting stuck in prosthesis." the product was not returned to depuy synthes, however photos were provided for review.See attachment a-10024349 source data.The photo investigation revealed that the tip of summit standard imp.Inserter was stripped.However the reported condition of jammed/seized for device remains unconfirmed.The observed condition was identified as an end of life indicator; damage 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.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the summit standard imp.Inserter would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to end of life 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.
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Manufacturer Narrative
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Product complaint (b)(4).Corrected: h3.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: consignment corail stem introduced has a damaged tip and is getting stuck in prosthesis.Instrument tagged as damaged.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that summit standard imp.Inserter.Has the distal tip of the device are severely worn and deformed.Additionally, the device shows an overall worn appearance consistent with normal and repetitive use.The observed condition prevents the instrument from assembling with mating devices, however the device was returned disengaged from the mating device, therefore, the device interaction allegation cannot be confirmed.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces like usage of excessive force in a prying motion while trialing.The overall complaint was confirmed as the observed condition of the summit standard imp.Inserter would contribute to the alleged device issue.Based on the investigation findings, the potential cause is traced to unintended user error, and it has been determined that no corrective and/or preventative action is proposed.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.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: according to the information received, "consignment corail stem introduced has a damaged tip and is getting stuck in prosthesis.".The product was not returned to depuy synthes, however photos were provided for review.See attachment a-10024349 source data.The photo investigation revealed that the tip of summit standard imp.Inserter was stripped.However the reported condition of jammed/seized for device remains unconfirmed.The observed condition was identified as an end of life indicator; damage 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.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the summit standard imp.Inserter would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to end of life 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.
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Search Alerts/Recalls
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