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WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI STERNAL LOCKING STRAIGHT PLATE/13 HOLES/WITHOUT PIN; PLATE, FIXATION, BONE
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| Model Number 460.046 |
| Device Problem
Break (1069)
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| Patient Problems
Inflammation (1932); Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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 Description
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It was reported that on or about (b)(6) 2018, patient underwent removal and replacement of synthes titanium external fixation system due to pain and implant breakage.Approximately 15 years ago, patient¿s right ribs were injured during strenuous horseplay around a pool.His ribs never properly healed from the injury, which resulted in a bone growth in his right ribs.The bone growth pinched the nerves in the area causing patient¿s muscle spasms and excruciating pain.On or about (b)(6) 2014, patient underwent resection of right 7 out of 8 ribs, with plating, using a synthes titanium sternal fixation system.In approximately (b)(6) 2017, while patient was resting at home, he felt a sudden painful snap in the area where the device was implanted.Following the incident, patient was in constant, intense pain and had experience grinding, and popping sensation in his torso and ribs in the area where the device was implanted.The implant has caused the patient to lose all stability in his chest and core and caused intense pain.The ongoing pain has disrupted the patient¿s activities of everyday living and prevented him from participating in activities he once enjoyed.On or about (b)(6) 2017, patient underwent imaging of his torso and ribs which revealed the implant to be split in half, approximately 1 inch from the end of the plate.On or about (b)(6) 2018, patient underwent surgery to have the synthes titanium external fixation system removed and replaced.After the removal, it was noted that the device had fractured approximately 1 inch from the end of the plate.On or about (b)(6) 2018, patient underwent imaging to ensure the successful replacement of the device.Patient still experienced ongoing inflammation in his rib joints, sternum, back shoulder, neck and right arm and, is still experiencing ongoing pain, and is no longer able to partake in the recreational activities he once enjoyed.This report is for one (1) sternal locking straight plate.This is report 1 of 1 for (b)(4).
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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.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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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.Part 460.046, lot 7260429: part manufacture date: february 19, 2013.Manufacturing location: elmira.A review of the device history record (dhr) revealed no complaint related anomalies.The device history record shows this lot of ti sternal locking straight plate/13 holes/without pin product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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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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.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 Description
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02/04/2019 updated event description: it was reported that on or about (b)(6) 2018, patient underwent removal and replacement of synthes titanium external fixation system due to pain and implant breakage.Approximately 15 years ago, patient¿s right ribs were injured during strenuous horseplay around a pool.His ribs never properly healed from the injury, which resulted in a bone growth in his right ribs.The bone growth pinched the nerves in the area causing patient¿s muscle spasms and excruciating pain.On or about (b)(6) 2014, patient underwent resection of right 7 out of 8 ribs, with plating, using a synthes titanium sternal fixation system.In approximately (b)(6) 2017, while patient was resting at home, he felt a sudden painful snap in the area where the device was implanted.Following the incident, patient was in constant, intense pain and had experience grinding, and popping sensation in his torso and ribs in the area where the device was implanted.The implant has caused the patient to lose all stability in his chest and core and caused intense pain.The ongoing pain has disrupted the patient¿s activities of everyday living and prevented him from participating in activities he once enjoyed.On or about (b)(6) 2017, patient underwent imaging of his torso and ribs which revealed the implant to be split in half, approximately 1 inch from the end of the plate.On or about (b)(6) 2018, patient underwent surgery to have the synthes titanium external fixation system removed and replaced.After the removal, it was noted that the device had fractured approximately 1 inch from the end of the plate.On or about (b)(6) 2018, patient underwent imaging to ensure the successful replacement of the device.Patient still experienced ongoing inflammation in his rib joints, sternum, back shoulder, neck and right arm and, is still experiencing ongoing pain, and is no longer able to partake in the recreational activities he once enjoyed.This complaint involves one (1) device.02/14/2019 update: this complaint has been re-opened due to additional information of patient's medical records and documentation received on february 14, 2019.
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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.Re-opened complaint and updated event description.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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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.Investigation summary : product was not returned.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.Update 22 feb 2019 for investigation based on provided images.(actual device not returned).Updated event description: it was reported that on or about (b)(6) 2018 , patient underwent removal and replacement of synthes titanium external fixation system due to pain and implant breakage.Approximately 15 years ago, patient¿s right ribs were injured during strenuous horseplay around a pool.His ribs never properly healed from the injury, which resulted in a bone growth in his right ribs.The bone growth pinched the nerves in the area causing patient¿s muscle spasms and excruciating pain.On or about (b)(6) 2014, patient underwent resection of right 7 out of 8 ribs, with plating, using a synthes titanium sternal fixation system.In approximately (b)(6) 2017 , while patient was resting at home, he felt a sudden painful snap in the area where the device was implanted.Following the incident, patient was in constant, intense pain and had experience grinding, and popping sensation in his torso and ribs in the area where the device was implanted.The implant has caused the patient to lose all stability in his chest and core and caused intense pain.The ongoing pain has disrupted the patient¿s activities of everyday living and prevented him from participating in activities he once enjoyed.On or about (b)(6) 2017, patient underwent imaging of his torso and ribs which revealed the implant to be split in half, approximately 1 inch from the end of the plate.On or about (b)(6) 2018, patient underwent surgery to have the synthes titanium external fixation system removed and replaced.After the removal, it was noted that the device had fractured approximately 1 inch from the end of the plate.On or about (b)(6) 2018, patient underwent imaging to ensure the successful replacement of the device.Patient still experienced ongoing inflammation in his rib joints, sternum, back shoulder, neck and right arm and, is still experiencing ongoing pain, and is no longer able to partake in the recreational activities he once enjoyed.This complaint involves one (1) device.Visual inspection: actual device was not returned.Visual inspection of the provided x-ray in complaint file "(b)(4) pa_chest 28jan2019" performed at customer quality (cq) confirmed the condition of post operative plate breakage, which agrees with the reported complaint condition.The x-ray shows the plate broken in situ.It appears that the plate broke just below the third most superior hole.Further details about the break profile/type could not be definitively determined from the provided images and because the device was not returned for analysis.Dhr review: a review of the device history records was unable to be performed since the lot number was unknown.Document/specification review: product design drawing was reviewed during this investigation.No product design issues or discrepancies were observed during this investigation.Conclusion: a definitive root cause for the post operative plate breakage could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation and the complaint condition is adequately covered by the risk assessment.No new, unique or different patient harms were identified as a result of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.
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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.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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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.Visual inspection: actual device was not returned.Visual inspection of the provided x-ray in complaint file performed at customer quality (cq) confirmed the condition of post operative plate breakage, which agrees with the reported complaint condition.The x-ray shows the plate broken in situ.It appears that the plate broke just below the third most superior hole.Further details about the break profile/type could not be definitively determined due to the poor image quality.Dhr review: a review of the device history records was unable to be performed since the lot number was unknown.Document/specification review: relevant product design drawing was reviewed during this investigation.No product design issues or discrepancies were observed during this investigation.This complaint was confirmed.Conclusion: a definitive root cause for the post operative plate breakage could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation and the complaint condition is adequately covered by the risk assessment.No new, unique or different patient harms were identified as a result of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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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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 number: 460.046.Lot number: 7288769.Part manufacture date: 20-mar-2013.Manufacturing location: elmira.Part expiration date: n/a.Nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of ti sternal locking straight plate/13 holes/without pin product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Visual inspection: the ti sternal locking straight plate/12 holes/without pin (p/n: 460.046, lot #: 7288769) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the device was broken just below the third most superior hole.There were scratches on the device consistent to explantation but have no impact on the functionality or the complaint condition.No other defects were identified with the returned devices.Device failure/defect identified? yes.Dimensional inspection: dimensional inspection was performed on the returned device.- the width of the device was measured to be within the specification.- the thickness of the device was measured to be within the specification.- the width of the device between the holes was measured to be the specification.Document/specification review based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed -ti sternal locking plate no product design issues or discrepancies were observed during this investigation.Complaint confirmed? yes, the device received was broken.Hence confirming the allegation.Investigation conclusion the complaint condition was confirmed for the ti sternal locking straight plate/12 holes/without pin (p/n: 460.046, lot #: 7288769).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.The potential root cause could be due to unintended forces applied to the device.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 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 Description
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Concomitant devices: ti sternal locking straight plate/13 holes/without pin (product code: 460.046, lot number: 7260429, quantity: 1).Unk - screws: trauma (product code: unknown, lot number: uknown, quantity: 13).
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