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

Model Number	UNKNOWN POLYSORB SUTURE
Medical Device Problem Codes	Device Slipped (1584); Use of Device Problem (1670)
Health Effect - Clinical Codes	Fistula (1862); Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946); Tissue Breakdown (2681)
Date of Event	02/20/2025
Type of Reportable Event	Serious 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.
Event or Problem Description
It was reported that during a total laryngectomy plus emptying, in reconstruction of tissues, the last knots of the suture were found to be loose, necessitating repeated stitches and causing tissue injury.Twenty-four hours postoperatively, an episode of bleeding occurred, prompting a review of the hemostatic surgical site by the otolaryngologist.Loose polysorb suture stitches were identified, there was increased diffuse bleeding from the surgical site, which required surgical revision, and increased salivary fistulas were observed in the post-surgical period.
Additional Manufacturer Narrative
Additional information: b5, g3.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 a total laryngectomy plus emptying , in reconstruction of tissues, the last knots of the suture was found to be loose, necessitating repeated stitches and causing tissue injury.Twenty-four hours postoperatively, an episode of bleeding occurred, prompting a review of the hemostatic surgical site by the otolaryngologist.Loose polysorb suture stitches were identified, there was increased diffuse bleeding from the surgical site, which required surgical revision, and increased salivary fistulas were observed in the post-surgical period.
Event or Problem Description
It was reported that during a total laryngectomy plus emptying , in reconstruction of tissues, the last knots of the two sutures were found to be loose, necessitating repeated stitches and causing tissue injury.Twenty-four hours postoperatively, an episode of bleeding occurred, prompting a review of the hemostatic surgical site by the otolaryngologist.Loose polysorb suture stitches were identified, there was increased diffuse bleeding from the surgical site, which required surgical revision, and increased salivary fistulas were observed in the post-surgical period.
Additional Manufacturer Narrative
Correction: b5, d10 d10.Concomitant products: gl-127, gl-127 polysorb* 2-0 vio 75cm v26 x36 (lot unknown) 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
Correction: d3 (mfr name, street 1, mfr city, country code, postal code), d4 (model #, catalog #).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 CT 0101 ; DR 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo CT 0101 ; DR 0101
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21626793
• Report Number: 1219930-2025-01273
• Device Sequence Number: 15130063
• Product Code: GAM
• UDI-Device Identifier: 10884521044982
• UDI-Public: 10884521044982
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: UNKNOWN POLYSORB SUTURE
• Device Catalogue Number: UNKNOWN POLYSORB SUTURE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 03/25/2025; 03/26/2025; 04/02/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 03/25/2025; 04/02/2025; 04/02/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown