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

Model Number	J267H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please verify the event- did the needle break or did the needle pull off from the suture? is the device available for evaluation? representative or actual broken needle? if either is available, please provide contact name, mailing address and phone number of the person to whom a shipper kit be sent to return the product.This medwatch report is in response to receipt of facility report # 4100120000-2019-8088.(b)(4).
Event or Problem Description
It was reported that a patient underwent a nail placement procedure in (b)(6) 2019 and suture was used.During the procedure, the suture broke off as the attending was closing the incision.Imaging taken to retrieve loose piece.Radiologist read and confirmed no pieces left in the patient with the attending surgeon.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 01/22/2020.A manufacturing record evaluation was performed for the finished device lot pgm835, and no non-conformances were identified.

• Brand Name: VCL CT BRD 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: 9558654
• Report Number: 2210968-2020-00165
• Device Sequence Number: 2866533
• Product Code: GAM
• UDI-Device Identifier: 10705031038394
• UDI-Public: 10705031038394
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2019

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: 05/31/2024
• Device Model Number: J267H
• Device Catalogue Number: J267H
• Device Lot Number: PGM835
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 01/22/2020
• Patient Sequence Number: 1
• Patient Weight: 60