MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 8X27IN 0 S/A CT-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	JJ31G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).A manufacturing record evaluation was performed for the finished device mkz596 batch number, and no non-conformance's were identified.Summary: received for analysis two detached needles and five sutures pieces of product code jj31g, lot mkz596.The product code is control release and required eight strands per packet.During the visual inspection of the detached needle, the swage and attachment area were noted to be as expected; however, no suture remnant at the barrel of the hole were observed.In addition, the suture was examined, and the impression of the swage area was not observed due to the end was cut appears to by use of a surgical instrument.According to the sample condition, it could not be determined what may have caused the reported incident of: ¿four of the strands broke off at the end of the needle¿.Representative samples: received for analysis six unopened samples of product code jj31g, lot mkz596.The product code is control release and required eight strands per packet.During the visual inspection of six unopened samples, no defects were found on the packages.The samples were opened, and swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects, or damaged were observed.A functional test was performed using an instron and the pull force were above the minimum requirements.Per the condition of the samples received, no performance pull off - suture needle was found, and the tested samples met the finished goods requirements.Events were submitted via medwatches 2210968-2020-02811, 2210968-2020-02812, 2210968-2020-02813 and 2210968-2020-02814.
Event or Problem Description
It was reported that the patient underwent a partial hysterectomy on (b)(6) 2020 and the suture was used.During the surgery, the suture detached/broke off from the needle during use.There were no patient consequences reported.

• Brand Name: VCL CT BRD VIO 8X27IN 0 S/A CT-1 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9941753
• Report Number: 2210968-2020-02811
• Device Sequence Number: 2164144
• Product Code: GAM
• UDI-Device Identifier: 10705031044111
• UDI-Public: 10705031044111
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• 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): 03/11/2020

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: 08/31/2023
• Device Model Number: JJ31G
• Device Catalogue Number: JJ31G
• Device Lot Number: MKZ596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 04/08/2020
• Patient Sequence Number: 1