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

Model Number	GM-122
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
Event or Problem Description
According to the reporter, pre-operatively, the thread of two sutures detached from the needle while being withdrawn from their retainers.Another suture was used to complete the case.There was no patient involvement.
Additional Manufacturer Narrative
D10 concomitant product: gm-122, gm-122 biosyn* 3-0 vio 75cm v20 x36, (lot # d4d3661y).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
H3 evaluation summary: medtronic conducted an investigation based upon all information received.Five sealed samples that were representative of the complaint lot were also returned.The visual inspection of the returned opened product noted one suture and one needle.One empty breather pouch was also returned.The needle was returned attached to the suture.The measurement was taken with an aluminum rule.The foil pouch was inspected and no signs of damage or abnormalities were identified.The visual inspection of the representative samples noted during light assisted microscopic inspection of the breathable pouches that there were 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 retainer.A tactile and microscopic inspection of the sutures were performed with no abnormalities.The foil pouches were inspected and identified no signs of damage or abnormalities.During simple knot/tensile test testing of the representative samples, 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 sutures and the knot was pulled tight.The suture ends were loaded onto an instron machine by clamping the ends with cord yarn grips.No suture breaking or fraying was noted while handling/loading the sutures into the instron machine.The instron then pulled the sutures at a rate until the sutures broke.The breaking point load force was measured and were found to meet usp (united states pharmacopeia) minimum mean and ep (european pharmacopoeia) minimum individual specifications.Based on the results of the simple knot test, the representative samples tested satisfactory.During needle attachment test of the representative s amples, 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 until the needle disengaged from the sutures.The load force at the point of detachment was measured and were found to meet usp (united states pharmacopeia) mean and individual specifications.Based on the results of the needle attachment test, the representative samples tested satisfactory.It was reported that the thread of two sutures detached from the needle while being withdrawn from their retainers.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: suture broken.Visual inspection noted that the suture was returned broken inches from the needle attachment point.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.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: BIOSYN
• 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: 24428579
• Report Number: 9612501-2026-00543
• Device Sequence Number: 18718088
• Product Code: GAM
• UDI-Device Identifier: 10884521032422
• UDI-Public: (01)10884521032422(17)290331(10)D4D3661Y(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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: GM-122
• Device Catalogue Number: GM-122
• Device Lot Number: D4D3661Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2024
• 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