MAUDE Adverse Event Report: ETHICON, INC. VICRYL RAPIDE; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	VR496
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial suture breakage malfunction events: 226.Initial suture breakage devices returned: 246.17 use error caused or contributed to event 192 no device failure.21 manufacturing deficiency.16 unable to confirm complaint.Initial needle breakage malfunction events: 102.Initial needle breakage devices returned: 161.20 use error caused or contributed to event.129 no device failure.3 manufacturing deficiency.9 unable to confirm complaint.Initial needle pull off malfunction events: 147.Initial needle pull off devices returned: 254.15 use error caused or contributed to event.159 no device failure.48 manufacturing deficiency.32 unable to confirm complaint.Follow-up suture breakage malfunction events: 16.Follow-up suture breakage devices returned: 41.1 use error caused or contributed to event.39 no device failure.0 manufacturing deficiency.1 unable to confirm complaint.Follow-up needle breakage malfunction events: 9.Follow-up needle breakage devices returned: 7.1 use error caused or contributed to event 1 no device failure.3 manufacturing deficiency.2 unable to confirm complaint.Follow-up needle pull off malfunction events: 17.Follow-up needle pull off devices returned: 43.5 use error caused or contributed to event.32 no device failure.4 manufacturing deficiency.2 unable to confirm complaint.All devices labeled for single use; 0 devices reprocessed and re-used 0 remedial action.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 517 malfunction events, including 242 suture breakage, 111 needle breakage and 164 detachment of device component that occurred intraoperatively.

• Brand Name: VICRYL RAPIDE
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON, INC.; po box 151; route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8023987
• Report Number: 2210968-2018-76847
• Device Sequence Number: 16481913
• Product Code: GAM
• UDI-Device Identifier: 10705031134690
• UDI-Public: 10705031134690
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K033746
• Number of Events Summarized: 517
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/04/2018

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 Catalogue Number: VR496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1