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| Model Number |
SC-643 |
| Medical Device Problem Code |
Detachment of Device or Device Component (2907)
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| Health Effect - Clinical Code |
No Clinical Signs, Symptoms or Conditions (4582)
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Type of Reportable Event
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Malfunction
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Additional Manufacturer Narrative
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D10.Concomitant products: sc-643, sc-643 caprosyn, 3-0 und 75cm sc2 x36, (lot d4a3964y); sc-643, sc-643 caprosyn, 3-0 und 75cm sc2 x36, (lot d4a3964y) medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event or Problem Description
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It was reported that during a procedure, in wound closure, the thread came loose from the needle.Additionally, on another suture, the thread broke in half during suturing.On the third suture, the needle comes loose from the thread when removed from the packaging.To resolve the issue, another suture was used.There was no patient injury.
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Additional Manufacturer Narrative
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Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.One opened and fifty-eight sealed devices were available for evaluation.Visual inspection of the opened device noted one suture thread.A needle was not returned.The suture thread was returned broken into three segments.Unfortunately, as the product was returned open, a tensile strength test could not be performed.Visual inspection of the representative devices noted no abnormalities.Functionally, the load force at the point of detachment was measured and the results were found to meet the mean and individual specifications for this product.It was reported that the thread came loose from the needle.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition of 'suture broken.' the most likely cause was determined to be manufacturing related.Internal process improvements have been initiated to mitigate this issue.The instructions included with this device provide the following guidance: progressive loss of tensile strength and eventual absorption of the absorbable sutures occurs by means of hydrolysis.This loss is triggered when exposed to the environment or clinical application.Damage during use may result in inadequate sample length to perform testing and/or deformation of the suture contributing to a loss in tensile strength.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Additional Manufacturer Narrative
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Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.One opened and fifty-eight representative devices were ava ilable for evaluation.Visual inspection noted that as the product was returned open, a tensile strength test could not be performed.The tensile strength of absorbable sutures may be affected by degradation of the suture and/or damage during use after the product has been opened and may impact the validity of any test results.The breathable pouches were opened without any tears of the tyvek packaging.The sutures were removed from the retainers without any difficulty.The sutures were loaded onto an instron machine by clamping the needle with a pneumatic grip with a serrated face and the suture end with a pneumatic yarn grip.Additionally, on another suture, the thread broke in half during suturing.On the third suture, the needle comes loose from the thread when removed from the packaging.It was reported that the thread came loose from the needle.The reported issue was confirmed.The most likely cause was determined to be manufacturing related.Internal process improvements have been initiated to mitigate this issue.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The evaluation detected an unreported condition of 'suture broken.' the suture was returned broken into three segments.The most likely cause was determined to be manufacturing related.Internal process improvements have been initiated to mitigate this issue.The instructions included with this device provide the following guidance: progressive loss of tensile strength and eventual absorption of the absorbable sutures occurs by means of hydrolysis.This loss is triggered when exposed to the environment or clinical application.Damage during use may result in inadequate sample length to perform testing and/or deformation of the suture contributing to a loss in tensile strength.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Additional Manufacturer Narrative
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Additional information: d9 (return date), g3, h3.Evaluation summary: medtronic conducted an investigation based upon all information received.One opened and fifty-eight sealed devices were available for evaluation.Visual inspection of the opened suture sample noted one suture thread.A needle was not returned.Visual inspection noted the suture was returned broken into three segments.Functional evaluation of representative samples noted the breathable pouches were opened without any tears of the tyvek packaging.The sutures were removed from the retainers without any difficulty.The sutures were loaded onto an instron machine by clamping the needle with a pneumatic grip with a serrated face and the suture end with a pneumatic yarn grip.No suture breakage or fraying was noted while handling or loading the sutures into the instron machine.The instron then pulled the sutures at a rate of 300 mm/min until the needle disengaged from the sutures.The load force at the point of detachment was measured and the results were found to meet ep mean and individual specifications.However, as two samples fell below that of the others tested.It was reported that the thread came loose from the needle.The reported issue was confirmed.The most likely cause was determined to be manufacturing related.Internal process improvements have been initiated to mitigate this issue.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The evaluation detected an unreported condition of suture broken.The most likely cause was determined to be manufacturing related.Internal process improvements have been initiated to mitigate this issue.The instructions included with this device provide the following guidance: progressive loss of tensile strength and eventual absorption of the absorbable sutures occurs by means of hydrolysis.This loss is triggered when exposed to the environment or clinical application.Damage during use may result in inadequate sample length to perform testing and/or deformation of the suture contributing to a loss in tensile strength.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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