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

Model Number	CL-803
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	03/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: cl-803 polysorb* 1 vio 75cm gs24 x36 (lot#: a5a1768y) cl-803 polysorb* 1 vio 75cm gs24 x36 (lot#: a5a1768y) cl-803 polysorb* 1 vio 75cm gs24 x36 (lot#: a5a1768y) cl-803 polysorb* 1 vio 75cm gs24 x36 (lot#: a5a1768y) cl-803 polysorb* 1 vio 75cm gs24 x36 (lot#: a5a1768y) cl-803 polysorb* 1 vio 75cm gs24 x36 (lot#: a5a1768y) cl-803 polysorb* 1 vio 75cm gs24 x36 (lot#: a5a1768y) cl-803 polysorb* 1 vio 75cm gs24 x36 (lot#: a5a1768y) cl-803 polysorb* 1 vio 75cm gs24 x36 (lot#: a5a1768y) cl-803 polysorb* 1 vio 75cm gs24 x36 (lot#: a5a1768y) cl-803 polysorb* 1 vio 75cm gs24 x36 (lot#: a5a1768y) cl-803 polysorb* 1 vio 75cm gs24 x36 (lot#: a5a1768y) cl-803 polysorb* 1 vio 75cm gs24 x36 (lot#: a5a1768y) cl-803 polysorb* 1 vio 75cm gs24 x36 (lot#: a5a1768y) cl-803 polysorb* 1 vio 75cm gs24 x36 (lot#: a5a1768y) cl-803 polysorb* 1 vio 75cm gs24 x36 (lot#: a5a1768y) cl-803 polysorb* 1 vio 75cm gs24 x36 (lot#: a5a1768y) 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 knee replacement, needle detachment occurred on the 18 sutures while removing the needle from the retainer.A product from a different lot number was used to resolve the issue.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.One opened, seventeen representative devices, and a photo were available for evaluation.Visual inspection of the opened suture sample noted one suture and one needle.The suture was returned partially wound within the retainer with the needle attached.Unfortunately, as the product was returned open, a needle attachment test could not be performed.Visual inspection of the representative suture samples noted no abnormalities.Functionally, the load force at the point of detachment was measured and the results were found to meet the mean and individual specifications for this product.The suture samples were also subjected to testing of the needle attachment force at 90° (degrees) of rotation.Results demonstrated forces typical of 90° attachment forces of this size suture.It was reported that the needle had detached.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.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): 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: 24865922
• Report Number: 1219930-2026-02430
• Device Sequence Number: 21470000
• Product Code: GAM
• UDI-Device Identifier: 10884521041868
• UDI-Public: (01)10884521041868(17)291231(10)A5A1768Y(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2026

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: CL-803
• Device Catalogue Number: CL-803
• Device Lot Number: A5A1768Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• 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
• Patient Sex: Unknown