Polysorb

Description of Event or Problem

It was reported that during a procedure, the needle detached from the suture. A total of four sutures from the same batch exhibited the same issue. An additional new suture was used without issue. The surgical procedure was extended for about 6 and half minutes since the nurse gad to get from the cabinet and then had to reload them onto the needle holder. There was no patient injury.

Additional Manufacturer Narrative

D10 Concomitant Products: CL-915, CL-915 POLYSORB* 1 VIO 90CM GS24 X36 (Lot#:A5J1624Y), CL-915, CL-915 POLYSORB* 1 VIO 90CM GS24 X36 (Lot#:A5J1624Y), CL-915, CL-915 POLYSORB* 1 VIO 90CM GS24 X36 (Lot#:A5J1624Y). 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.