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

Model Number	CL-812
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	01/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Correction: e1 (facility name, street 1) 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 products: cl-812 cl-812 polysorb* 0 vio 75cm gs21 x36 - (lot#a5d1596y); cl-812 cl-812 polysorb* 0 vio 75cm gs21 x36 - (lot#a5d1596y); cl-812 cl-812 polysorb* 0 vio 75cm gs21 x36 - (lot#a5d1596y); 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 a procedure, while performing a continuous suture, the needle unexpectedly detached itself.The same issue occurred on three other sutures from the same batch.Sewing was performed to resolve the issue.There was no patient injury.
Additional Manufacturer Narrative
Correction: a2, a3a.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
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
According to the reporter, during a total hip replacement procedure, while performing a continuous suture, the needle unexpectedly detached itself.The same issue occurred on three other sutures from the same batch.Sewing was performed to resolve the issue.There was no patient injury.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The involved device was not returned.Visual inspection noted the visual inspection of the opened sample noted one needle.The suture was not returned.The needle was returned disengaged from the suture.Under microscopic inspection, instrument marks were noted near the swaged end of the needle.Visual inspection and physical evaluation of the representative samples noted no abnormalities.However, evaluation noted as follows: in addition to testing against ep specifications, the samples were subjected to testing of the needle attachment force at 90° (degrees) of rotation following discussions with design engineering.Results demonstrated lower forces than are typical for 90° attachment forces of this usp size suture.No design specification or regulatory requirements exists for 90° attachment force.It was reported that the needle unexpectedly detached itself.The reported issue was confirmed.The most likely cause was determined to be manufacturing related.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: 24121322
• Report Number: 1219930-2026-00363
• Device Sequence Number: 6050579
• Product Code: GAM
• UDI-Device Identifier: 10884521049697
• UDI-Public: (01)10884521049697(17)300331(10)A5D1596Y(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/08/2026

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-812
• Device Catalogue Number: CL-812
• Device Lot Number: A5D1596Y
• 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: 01/13/2026
• Supplement Date Received by Manufacturer: 01/21/2026; 02/09/2026; 02/10/2026; 04/03/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 01/23/2026; 02/09/2026; 02/10/2026; 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2025
• 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
• Patient Age: 74 YR
• Patient Sex: Male