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

Model Number	SL-5687
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	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant products: sl-5687, sl-5687 polysorb* 5-0 und 45cm p13 x36 (lot#:d4a3430fy), sl-5687, sl-5687 polysorb* 5-0 und 45cm p13 x36 (lot#:d4a3430fy), sl-5687, sl-5687 polysorb* 5-0 und 45cm p13 x36 (lot#:d4a3430fy), sl-5687, sl-5687 polysorb* 5-0 und 45cm p13 x36 (lot#:d4a3430fy), sl-5687, sl-5687 polysorb* 5-0 und 45cm p13 x36 (lot#:d4a3430fy), sl-5687, sl-5687 polysorb* 5-0 und 45cm p13 x36 (lot#:d4a3430fy), sl-5687, sl-5687 polysorb* 5-0 und 45cm p13 x36 (lot#:d4a3430fy), sl-5687, sl-5687 polysorb* 5-0 und 45cm p13 x36 (lot#:d4a3430fy), sl-5687, sl-5687 polysorb* 5-0 und 45cm p13 x36 (lot#:d4a3430fy), sl-5687, sl-5687 polysorb* 5-0 und 45cm p13 x36 (lot#:d4a3430fy), sl-5687, sl-5687 polysorb* 5-0 und 45cm p13 x36 (lot#:d4a3430fy), sl-5687, sl-5687 polysorb* 5-0 und 45cm p13 x36 (lot#:d4a3430fy), sl-5687, sl-5687 polysorb* 5-0 und 45cm p13 x36 (lot#:d4a3430fy), sl-5687, sl-5687 polysorb* 5-0 und 45cm p13 x36 (lot#:d4a3430fy), sl-5687, sl-5687 polysorb* 5-0 und 45cm p13 x36 (lot#:d4a3430fy), sl-5687, sl-5687 polysorb* 5-0 und 45cm p13 x36 (lot#:d4a3430fy), sl-5687, sl-5687 polysorb* 5-0 und 45cm p13 x36 (lot#:d4a3430fy), sl-5687, sl-5687 polysorb* 5-0 und 45cm p13 x36 (lot#:d4a3430fy), sl-5687, sl-5687 polysorb* 5-0 und 45cm p13 x36 (lot#:d4a3430fy), sl-5687, sl-5687 polysorb* 5-0 und 45cm p13 x36 (lot#:d4a3430fy), sl-5687, sl-5687 polysorb* 5-0 und 45cm p13 x36 (lot#:d4a3430fy), sl-5687, sl-5687 polysorb* 5-0 und 45cm p13 x36 (lot#:d4a3430fy), sl-5687, sl-5687 polysorb* 5-0 und 45cm p13 x36 (lot#:d4a3430fy), sl-5687, sl-5687 polysorb* 5-0 und 45cm p13 x36 (lot#:d4a3430fy) 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 open surgical skin suturing procedure, the suture needle and thread broke while suturing skin.95 sutures were used and had the same issue.The suture was replaced with another manufacturer's product to complete the case.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.Twenty-six sutures opened by the account and sixty nine sealed representative samples were available for evaluation.Visual inspection of the opened sutures noted thirteen needles attached to the sutures, six sutures without the needles, and seven needle detached with their sutures.Upon microscopic inspection of the disengaged needles, normal crimp and swage marks were noted.Suture material was observed to be present in the swages, indicating the sutures broke off at the swage.Visual inspection of the representative samples noted no abnormalities.During functional testing of the representative samples, one suture broke while removing the needle from the package.The units that were then submitted to humidity test and all of them failed since the values were above the expected.Units were also submitted to needle holding strength and knot pull test and all of them failed the test.Dye penetration leak testing was performed to the foils of the thirty samples received and twenty-nine of them failed the test and one passed.It was reported that the needle and thread broke.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 m edtronic 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: POLYSORB
• 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: 24454703
• Report Number: 9612501-2026-00576
• Device Sequence Number: 21333898
• Product Code: GAM
• UDI-Device Identifier: 10884521048775
• UDI-Public: (01)10884521048775(17)281231(10)D4A3430FY(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K963253
• 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): 06/09/2026

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: SL-5687
• Device Catalogue Number: SL-5687
• Device Lot Number: D4A3430FY
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2024
• 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