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

Model Number	GLS-122
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the breathable pouches and foil pouches indicated no breaches or abnormalities.The sutures were observed to be properly wound within the retainer.A tactile and microscopic inspection of the sutures was performed and identified no damage or visual abnormalities.No difficulty was experienced removing the sutures from the retainer.The wire diameter of the needles was verified to be 0.025 inches.The measurement was made with a micrometer.A bend moment test was performed on the sealed samples and test results met the minimum bend moment specification for this product, 550 grams of force per centimeter.Based on the results of the bend moment test, the representative samples tested satisfactory.Functional testing found that the opened complaint device was precluded as the needle was returned broken.It was reported that the needle broke.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur if the needle is grasped near the swaged end or the tip and could cause bends, breaks, or damage the connection between the needle and suture.The manufacturing records for each device are th oroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: avoid crushing or crimping damage due to application of surgical instruments, such as forceps or needle holders.The customer is advised to grasp the needle by the middle section, where the diameter is greatest.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
D10: concomitant product: sm-5627, sm-5627 biosyn 4-0 und 45cm p12 x12, (lot number: d5c4609fy).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 pacemaker insertion, two sutures were found to be defective during the same event with the same patient, with one needle breaking and another needle detaching.An additional new suture was used without issue.No patient complications have been reported as a result of this event.

• 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: 23001122
• Report Number: 9612501-2025-02379
• Device Sequence Number: 18351157
• Product Code: GAM
• UDI-Device Identifier: 10884521045620
• UDI-Public: (01)10884521045620(17)280831(10)D3J1690Y(20)01
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

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: GLS-122
• Device Catalogue Number: GLS-122
• Device Lot Number: D3J1690Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2023
• 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 Age: 77 YR
• Patient Sex: Unknown