MAUDE Adverse Event Report: COVIDIEN SURGICAL POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC

Model Number	CLT-957
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	01/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: clt-957; clt-957 polysorb* 0 vio 75cm btp1 x36; (lot number: a5a2014y) clt-957; clt-957 polysorb* 0 vio 75cm btp1 x36; (lot number: a5a2014y) clt-957; clt-957 polysorb* 0 vio 75cm btp1 x36; (lot number: a5a2014y) clt-957; clt-957 polysorb* 0 vio 75cm btp1 x36; (lot number: a5a2014y) clt-957; clt-957 polysorb* 0 vio 75cm btp1 x36; (lot number: a5a2014y) h3 evaluation summary: medtronic conducted an investigation based upon all information received.One opened and forty-five representative devices were avai lable for evaluation.Visual inspection of the opened sample identified one needle and one suture, with the needle returned disengaged.Microscopic examination of the needle showed normal crimp and swage marks with suture material present within the swage, indicat ing separation at the attachment point.Dark heat tipping was observed at the suture end, and inspection of the foil pouch revealed no damage or abnormalities.Evaluation of representative samples found no breaches or damage to the breathable pouches, while tactile and microscopic inspection of the sutures noted varying degrees of dark discoloration and increased stiffness near the needle attachment areas.It was reported that multiple needles and thread were either broken upon opening or fractured during the procedure.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 medtronic 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.
Event or Problem Description
According to the reporter, during the laparoscopic myomectomy, while in the uterus, the multiple needles and thread were either broken upon opening or fractured during the procedure.Another device from another lot number was used to complete the case.There was no patient injury.

• Brand Name: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC
• Manufacturer (Section D): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 24767671
• Report Number: 1219930-2026-02174
• Device Sequence Number: 9298490
• Product Code: GAM
• UDI-Device Identifier: 10884521044791
• UDI-Public: (01)10884521044791(17)300131(10)A5B1180Y(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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2026

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: CLT-957
• Device Catalogue Number: CLT-957
• Device Lot Number: A5B1180Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2025
• 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 COMMENT ON H11.
• Patient Sex: Unknown