Catalog Number 227425800 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2023 |
Event Type
malfunction
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Event Description
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It was reported that drill bit is broken off.Patient status/ outcome / consequences: 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)(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).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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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary: according to the information received, "drill bit broken off".The product was not returned to depuy synthes.However ,photo was provided for review.The photo investigation revealed, that the tip of 227425800, pin rev dome drill 25mm was broken.This condition is consistent with multiple uses under extreme eccentric loading.Resulting, in premature bending or failure of the drill bit.However, taking in consideration, the age of the device (insert device age if applicable).The potential cause can be attributed to end of life.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 227425800, pin rev dome drill 25mm would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced 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 # = > pc-(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.H10 additional narrative: added: d9 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H3.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: according to the information received, "drill bit broken off" the product was not returned to depuy synthes, however photo was provided for review.The photo investigation revealed that the tip of 227425800, pin rev dome drill 25mm was broken.This condition is consistent with multiple uses under extreme eccentric loading resulting in premature bending or failure of the drill bit, however taking in consideration the age of the device (insert device age if applicable) the potential cause can be attributed to end of life.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 227425800, pin rev dome drill 25mm would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced 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).Investigation summary: it was reported that drill bit broken off.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that pin rev dome drill 25mm was found broken from fluted tip.The broken fragment was not returned for examination.Therefore, the reported condition can be confirmed.This condition is consistent with multiple uses under extreme eccentric loading resulting in premature bending or failure of the drill bit, the potential cause can be attributed to end of life.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.A dimensional inspection was unable to be performed due to post manufacturing damage.A functional test was unable to be performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the pin rev dome drill 25mm would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.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.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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