MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	GL-224
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during fascia closure, the needle broke.The surgeon realized that the needle was broken at its end after the completion of the 2nd point.A piece of the needle was at the operative site.Removing the needle piece from the surgical site and using another wire for the rest of the procedure.There was no patient injury.

• Brand Name: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 8123165
• Report Number: 1219930-2018-06443
• Device Sequence Number: 16532274
• Product Code: GAM
• UDI-Device Identifier: 10884521045163
• UDI-Public: 10884521045163
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2018

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 Expiration Date: 09/30/2022
• Device Model Number: GL-224
• Device Catalogue Number: GL-224
• Device Lot Number: A7J0571X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 12/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1