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

Model Number	GSJ-33-M
Medical Device Problem Code	Detachment of Device or Device Component (2907)
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 a procedure, the four needles detached from the thread.Another suture was used to resolve the issue.There was no patient injury.
Additional Manufacturer Narrative
D10 concomitant product: gsj-33-m, gsj-33-m sofsilk 3/0 blkcv-25dt5x45cmx24 (lot#d4f2770y); gsj-33-m, gsj-33-m sofsilk 3/0 blkcv-25dt5x45cmx24 (lot#d4f2770y); 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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the visual inspection of the returned product noted five sutures and five needles.One needle were returned disengaged from any suture.Four needles had sutures attached and properly parked within the retainer.One sutures were disengaged from any needle.Upon microscopic inspection of the needles, normal crimp and swage marks were noted.Functional testing found that a needle attachment test was performed with the properly wound sutures from plis 10 through 40.Unfortunately, a needle attachment test could not be tested on the already detached needles and exposed sutures.The tensile strength of nonabsorbable sutures may be affected by damage during use after the product has been opened and may impact the validity of any test results.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.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 of 300 mm/min until the needle disengaged from the suture.The load force at the point of detachment was measured and were found to meet usp specifications.It was reported that the needle was detached.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.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: 21054782
• Report Number: 9612501-2025-00005
• Device Sequence Number: 8656716
• 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
• Report Date (Section B): 03/07/2025

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: D4F2770Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2024
• 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: 03/05/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2024
• 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: PLEASE SEE NOTE ON H11
• Patient Sex: Unknown