MAUDE Adverse Event Report: ETHICON INC. MCRYL+ VIO 36IN 2-0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	MCP345H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device (b)(4) batch number, and no non-conformances were identified investigation summary: one open sample of product code (b)(4), lot pkz913 was received for analysis.During the visual inspection of the needle the swage and attachment area were as expected.The barrel hole of the needle was examined under magnification and no suture remnant was noted.The suture was examined, and the insertion did not meet the requirement. the manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition, the assignable cause pull off - suture needle is short insertion.This defect is caused because the insertion of the suture in the needle was insufficient from keep the needle/suture union during transportation or use.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a canine underwent a ovariohysterectomy and suture was used.The doctor grasped needle and there was no suture attached.Another suture was used.Upon return of the device and evaluation, the barrel hole of the needle was examined under magnification and no suture remnant was noted.The suture was examined, and the insertion did not meet the requirement.No additional information was provided.

• Brand Name: MCRYL+ VIO 36IN 2-0 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10180137
• Report Number: 2210968-2020-04703
• Device Sequence Number: 11298557
• Product Code: GAM
• UDI-Device Identifier: 10705031046429
• UDI-Public: 10705031046429
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K050845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2020

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: 08/31/2021
• Device Model Number: MCP345H
• Device Catalogue Number: MCP345H
• Device Lot Number: PKZ913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 06/22/2020
• Patient Sequence Number: 1