MAUDE Adverse Event Report: ETHICON, INC. VICRYL POLYGLACTIN 910 SUTURE; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	V448G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Suture breakage malfunction events: 222.Suture breakage devices returned: 385.Manufacturing deficiency: 12.Needle breakage malfunction events: 89.Needle breakage devices returned: 155.Manufacturing deficiency - 8.Needle pull off malfunction events: 192.Needle pull off devices returned: 297.Manufacturing deficiency - 6.All devices labeled for single use; 0 devices reprocessed and re-used.0 remedial action.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Complaint information will be included in complaint trending that is reviewed on a regular basis to determine if further action is necessary.
Event or Problem Description
This report summarizes 458 initial malfunction events, including 188 suture breakage, 81 needle breakage and 189 needle pull-off that occurred intraoperatively.It also summarizes 45 follow up malfunction events, including 34 suture breakage, 8 needle breakage and 3 needle pull-off that occurred intraoperatively.

• Brand Name: VICRYL POLYGLACTIN 910 SUTURE
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON, INC.; po box 151; route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8289417
• Report Number: 2210968-2019-78625
• Device Sequence Number: 2701459
• Product Code: GAM
• UDI-Device Identifier: 10705031051256
• UDI-Public: 10705031051256
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 458
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/06/2018

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: 04/30/2022
• Device Catalogue Number: V448G
• Device Lot Number: LEM566
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1