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

Model Number	GLJ-51-M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: vlocl0336 v-loc 180 0 grn 60cm gs21x12 - vlocl0336, lot# a3m1580vy vlocl0336 v-loc 180 0 grn 60cm gs21x12 - vlocl0336, lot# a3m1580vy glj-51-m polysorb* 4/0viocv-25dt 5x45x12 - glj-51-m, lot# d3h2233y 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 laparoscopic radical gastrectomy, the two polysorb threads broke three minutes into the procedure during the interrupted suture of the gastroduodenal anastomosis.Additionally, the two vloc threads broke one minute into the continuous suture of fascia and muscle, with the one vloc sture breaking after the first knot was locked.To resolve the issue, another brand of suture was used to complete the suturing.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: d9, 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 sutures were returned broken.The needles were returned disengaged from their sutures.Upon microscopic inspection of the needles, normal crimp and swage marks were noted.It was reported that the suture was broken.The reported issue was confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: of needle detached that has no relationship to the reported condition.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.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.This loss is triggered when exposed to the environment or clinical application.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.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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21598978
• Report Number: 9612501-2025-00752
• Device Sequence Number: 8939311
• Product Code: GAM
• UDI-Device Identifier: 10884521045552
• UDI-Public: 10884521045552
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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: GLJ-51-M
• Device Catalogue Number: GLJ-51-M
• Device Lot Number: D3H2233Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2023
• 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: Male