MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 1 S/A CP-1; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z468H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Not Applicable (3189)
Date of Event	10/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device pcm547 batch number, and no non-conformances were identified.Attempts are being 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.The following information was requested but unavailable: the patient demographic info: age, gender, weight, bmi at the time of index procedure.Date and name of index surgical procedure.The diagnosis and indication for the index surgical procedure? in what tissue was the suture placed? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? was there any precipitating stress factor for the suture breakage or pulling out of the tissue? other relevant patient history/concomitant medications.What is physician¿s opinion as to the etiology of or contributing factors to this event? additional information was requested and the following was obtained: if applicable, will the product be returned, return date, tracking information: no.Product to be returned, but returned the last 2 sutures of the pack for evaluation.What is physician¿s opinion as to the etiology of or contributing factors to this event? unknown.What is the patient¿s current status? patient had to go back to theatre for a laparotomy to repair the wound.
Event or Problem Description
It was reported that the patient underwent an unknown gynecological procedure on an unknown date and suture was used.The patient¿s wounds opened post-op within 24 hours.The suture broke in the middle of the suture line, it was a continuous suturing technique.The surgeon had to take the patient back to theatre to close the wound via laparotomy.It is unknown if the patient had any infections or other co-morbidities.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Device evaluation summary: two unopened samples of product code z4687, lot # pcm547 were returned for analysis.The complaint sample was not received.During the visual inspection of two unopened samples, no defects were found on the packages.The samples were opened, and the 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, damaged or suture breakage were noted.A functional test was performed and the tensile strength force was above the minimum requirement.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the representative samples, no performance - breakage suture was found and the tested samples met the finished goods requirements.Representative samples returned to support investigation of 2 device issues captured in reports 2210968-2019-89620 and 2210968-2019-89653.Analysis results have been included in mw reports for each.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 1/8/2020.Patient code: (b)(6).

• Brand Name: PDSII VIO 27IN 1 S/A CP-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9286495
• Report Number: 2210968-2019-89620
• Device Sequence Number: 2448602
• Product Code: NEW
• UDI-Device Identifier: 10705031061095
• UDI-Public: 10705031061095
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: N18331
• 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,Followup,Followup
• Report Date (Section B): 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: Z468H
• Device Lot Number: PCM547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 12/03/2019; 01/08/2020
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 12/20/2019; 01/08/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention