MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE SUTURE; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	8682G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Organ Dehiscence (2502); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) date sent to the fda: 08/17/20160 (b)(4).Additional information: the actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: batch# (b)(4) batch# (b)(4) batch# (b)(4) batch# (b)(4) batch# (b)(4) batch# (b)(4) batch# (b)(4) batch# (b)(4) in addition, a review of the batch manufacturing records for the possible batch numbers was conducted and the batches met all finished goods release criteria.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 for each of the 9 patients and the following was obtained: patient pre-operative diagnosis and indication for surgery: basal cell carcinoma, squamous cell carcinoma or melanoma.Procedure name: repair after mohs surgery or wide local excision.Product code and lot number involved: 5-0 prolene pc-1 and 4-0 prolene ps-2.How was the suture placed (interrupted or continuous)? continuous.How was the suture tied (2 strands that meet in the middle or knots at ends)? knots at end dates and timelines that patients symptoms first began following the initial surgery and what were the symptoms ? suture broken in middle of running stitch.Was there any pre dehiscence event (cough, fall, deep breathing or lifting)? no.Were any pictures taken during the second procedure? no.What was used to close the incision? 5-0 monocryl and 5-0 prolene pc-1 or 4-0 monocryl and 4-0 prolene ps-2.Any product to return for evaluation: - 5-0 prolene pc-1 and 4-0 prolene ps-2.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.Initial procedure date can you describe the tissue condition when the suture was placed? please provide details of any medical or surgical interventions performed and dates can you describe the appearance of the suture during the second procedure? what in the physicians opinion are the factors contributing to the event? patient demographics: initials / id; age or date of birth; height/weight/bmi; gender.Relevant patient medical and social history (ie.Obesity, diabetes, immune deficient or immune -compromised).Update to patient current condition.
Event or Problem Description
It was reported that the patient underwent a repair after mohs surgery or wide local excision procedure on unknown date and the suture was used on the surface of the skin in a continuous loop and knots at the end.Ten days after the procedure, the patient returned with dehiscence and the suture was broken in the middle of running stitch.The patient was re-sutured and released.
Additional Manufacturer Narrative
Date sent to fda: 9/16/2016.Additional information: the actual device batch number associated with this event is not known.The customer reported the additional following possible batch number: batch# kbp878; exp.Date 01/31/2021; mfr date: 02/10/2016.In addition, a review of the batch manufacturing records for the additional possible batch number was conducted and the batch met all finished goods release criteria.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.This mfr #2210968-2016-11355 follow up 1 has been submitted upon request from fda to submit a missing mfr mdr report.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.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: surgeon used continuous baseball stitch with prolene on face.There were no reported intra op suture breakage concerns.

• Brand Name: PROLENE POLYPROPYLENE SUTURE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 5881874
• Report Number: 2210968-2016-11355
• Device Sequence Number: 1504185
• Product Code: GAW
• UDI-Device Identifier: 10705031018884
• UDI-Public: 10705031018884
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/25/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 8682G
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2016
• Supplement Date Received by Manufacturer: 08/19/2016; 08/19/2016; Not provided
• Initial Report FDA Received Date: 08/17/2016
• Supplement Report FDA Received Date: 03/25/2024; 03/25/2024; 09/27/2016
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MONOCRYL 4-0; MONOCRYL 4-0
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown