MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SOFSILK; SUTURE, NONABSORBABLE, SILK

Model Number	GSJ-33-M
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during gastrointestinal suturing, d-tuch was reported as being hard, one of the suture cited for its hardness.There was no patient injury.
Additional Manufacturer Narrative
D10 concomitant product: gsj-33-m, gsj-33-m sofsilk 3/0 blkcv-25dt5x45cmx24 (lot#d4f2770y).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
According to the reporter, during gastrointestinal suturing d-tach was not functioned smoothly.The connection between the needle and thread was stiff and difficult to detach.A new device was used to resolve the issue.There was no patient injury.
Additional Manufacturer Narrative
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.The device was opened by the account with the appropriate packaging and eleven sealed representative samples were available for evaluation.Visual inspection noted that the opened sample has three suture and five needles.Two of the needles were returned disengaged from the suture.Upon microscopic inspection of the needle, normal crimp and swage marks were noted.Visual and tactile inspection of the returned sutures noted no stiffness or other visual abnormalities.A tactile and microscopic inspection of the sealed sutures was performed with no abnormalities.Microscopic inspection of the needles noted no abnormalities.Functional testing on the sealed samples found that a needle attachment test was performed on the returned representative samples.The breathable pouch was 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 breaking or fraying was noted while handling/loading the suture into the instron machine.The instron then pulled the suture at a rate that was within specifications.It was also reported that the connection between the needle and thread was stiff and difficult to detach.The reported issues could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: needle detached.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.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: SOFSILK
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21067004
• Report Number: 9612501-2025-00041
• Device Sequence Number: 3277573
• Product Code: GAP
• UDI-Device Identifier: 20884521085302
• UDI-Public: 20884521085302
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K981128
• 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,Followup
• Report Date (Section B): 03/05/2025

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: GSJ-33-M
• Device Catalogue Number: GSJ-33-M
• Device Lot Number: D4E4419Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 12/19/2024; 02/27/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 01/06/2025; 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2024
• 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
• Patient Sex: Unknown