MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 27IN 0 S/A CP-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP267H
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
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested, and the following was obtained: was the broken needle piece retained in patient? if yes, how was it retrieved? remains in the patient.Was there any adverse consequence associated with the patient? unknown are there any future interventions; including x-ray planned to locate the broken needle tip? unknown.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.
Event or Problem Description
It was reported that a patient underwent a left total hip replacement procedure on an unknown date; and suture was used.During the procedure, the needle tip broke upon closing the deep fascia.It was unknown how the case was completed.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: VCL+ UD 27IN 0 S/A CP-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: 10755758
• Report Number: 2210968-2020-08444
• Device Sequence Number: 16400031
• Product Code: GAM
• UDI-Device Identifier: 10705031051874
• UDI-Public: 10705031051874
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/12/2020

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 Model Number: VCP267H
• Device Catalogue Number: VCP267H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1