MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 36IN 1 S/A CTX; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J977H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	02/01/2020
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.Additional information was requested and the following was obtained: was the procedure completed successfully? yes.Are any plans in place to remove the needle piece in future? no.Was there any additional tissue damage as a result of searching for the needle piece? no.Could you please provide lot number please? picture of packaging attached.No further information available at this time.Unfortunately the product was discarded in error by the dept.Investigation summary: two photos were provided for analysis.Upon visual inspection of the pictures, two needle-sutures were noted; however, the tip of one of needles appears to be broken and one foil of product code (b)(4) could be observed.No conclusion could be reach as the sample was not returned for analysis.The manufacturing records couldn't be reviewed as the batch number is unknown.
Event or Problem Description
It was reported that a patient underwent a cesarean section delivery in (b)(6) 2020 and suture was used.During the procedure, the tip of the needle was noticed to be broken after picked up to put in needle board.The surgeon was informed.The surgeon checked the abdomen, irrigated, completed thorough search of wound including ran through suture holes.Drapes were also checked, unable to locate tip.Due to the size of the tip, provider refused xray.It is unknown how the case was completed, however, the procedure was completed successfully.There were no patient consequences reported.No additional information was provided.

• Brand Name: VCL CT BRD UD 36IN 1 S/A CTX
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9958114
• Report Number: 2210968-2020-03007
• Device Sequence Number: 14155321
• Product Code: GAM
• UDI-Device Identifier: 10705031043794
• UDI-Public: 10705031043794
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 03/10/2020

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: J977H
• Device Catalogue Number: J977H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 04/14/2020
• Patient Sequence Number: 1
• Patient Age: 39 YR