MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 27IN 1 S/A CPX; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP569H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Adverse events will be submitted via 2210968-2020-05110, 2210968-2020-05509, 2210968-2020-05510, and 2210968-2020-05511.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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 patient underwent an orthopedic uni knee procedure on (b)(6) 2020 and suture was used.During the procedure, the suture came out of the swage.Repeated and the case was finished with same suture of a different lot number.The procedure was completed successfully with no adverse patient consequences.

• Brand Name: VCL+ UD 27IN 1 S/A CPX
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10315417
• Report Number: 2210968-2020-05510
• Device Sequence Number: 19486129
• Product Code: GAM
• UDI-Device Identifier: 10705031054196
• UDI-Public: 10705031054196
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/08/2020

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: 10/31/2024
• Device Model Number: VCP569H
• Device Catalogue Number: VCP569H
• Device Lot Number: PMZ374
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 07/23/2020
• Patient Sequence Number: 1