MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD MAXON; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC

Model Number	8886663241
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: 8886663241, 8886 6632-41 maxon 3-0 clr 75cm p12x36 (lot#:d4m2145fy).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.
Event or Problem Description
It was reported that during an abdominoplasty procedure, the needle broke off from the thread.On the second device, the thread broke in the middle while the user was pulling it through the tissue.Additional new sutures were used without issue.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Correction: h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Representative samples were returned.Visual inspection of the opened samples noted one suture and two needles.One needle (sample/ needle a) was disengaged from it's suture.The other needle (sample/ needle b) was attached to the suture.The suture was returned broken from the needle attachment point.The measurement was taken with an aluminum rule, calibrated asset.Upon microscopic inspection of the needles, normal crimp and swage marks were noted.The foil pouches were inspected and no signs of damage or abnormalities were identified.Visual inspection of the representative samples noted light assisted microscopic inspection of the breathable pouches noted no breaches or damage.The needles were properly parked in the retainers.Inspection of the retainers noted the sutures were properly wound and no damage to the retainers.A tactile and microscopic inspection of the sutures was performed with no abnormalities.The foil pouches were inspected and no signs of damage or abnormalities were identified.Functional testing of the representative samples revealed that 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/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.Based on the results of the needle attachment test, the representative samples tested satisfactory.It was reported that the needle broke off from the thread.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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.
Additional Manufacturer Narrative
Additional information: d9 (return date), g3, h3, h6 h3.Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Representative samples were returned as well.Visual inspection noted that the opened samples noted one suture and two needles.One needle (sample/ needle a) was disengaged from its suture.The other needle (sample/ needle b) was attached to the suture.The suture was returned broken from the needle attachment point.The measurement was taken with an aluminum rule, calibrated asset.Upon microscopic inspection of the needles, normal crimp and swage marks were noted.The foil pouches were inspected and no signs of damage or abnormalities were identified.Visual inspection of the representative samples noted light assisted microscopic inspection of the breathable pouches noted no breaches or damage.The needles were properly parked in the retainers.Inspection of the retainers noted the sutures were properly wound and no damage to the retainers.A tactile and microscopic inspection of the sutures was performed with no abnormalities.The foil pouches were inspected and no signs of damage or abnormalities were identified.Functional testing of the representative samples revealed that the breathable pouches were opened without any tears of the tyvek packaging.The sutures were removed from the retainers without any difficulty.A simple knot was performed on the suture and the knot was pulled tight.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/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 and the suture broke.The load force at the point of detachment was measured and the results were found to meet ep mean and individual specifications.Based on the results of the needle attachment test and simple knot test, the representative samples tested satisfactory.It was reported that the needle broke off from the thread.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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.

• Brand Name: MAXON
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23358326
• Report Number: 9612501-2025-02764
• Device Sequence Number: 8824163
• Product Code: GAM
• UDI-Device Identifier: 10884521114883
• UDI-Public: (01)10884521114883(17)291130(10)D4M2145FY(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K990951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8886663241
• Device Catalogue Number: 8886663241
• Device Lot Number: D4M2145FY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 12/10/2025; 12/26/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 12/26/2025; 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Sex: Unknown