MAUDE Adverse Event Report: ETHICON INC. STFX SPI MCRYL+ UNI 6IN 4-0 UD; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Catalog Number	SXMP1B434
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a bariatric procedure on (b)(6) 2023 and barbed suture was used.During surgery, the needle type was found to be cutting needle when opened the package, but actually it should be a taper needle.Changed to another one to complete the surgery.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6.Component code: g07002 - device not returned.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.This report is being submitted pursuant to the provisions of 21 cfr part 803, part 4 subpart b.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, or its employees that the report constitutes an admission that the product, ethicon, 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 Manufacturer Narrative
Product complaint (b)(4).Date sent to the fda: 12/18/2023.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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, or its employees that the report constitutes an admission that the product, ethicon, 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.H3 investigational summary: the product was returned to ethicon for evaluation.Visual was conducted on the returned device.The returned sample determined that it received one open sample that pertained to the product code sxmp1b434, lot tcbjtr.Upon initial inspection of the returned sample, it was observed that the printed description of the needle on the foil did not match the needle received for analysis.Also, the hologram print on the tray was scanned and showed a different lot number (tbbaze) of the foil returned.Due to the mismatch observed, a further investigation was performed at san angelo site and san lorenzo site with the results mentioned as follows: they found 40 days of difference in the bounding between lot tbbaze and lot tcbjtr.There was no overlapping between these lots at san lorenzo site at any point in time.28 days between lot tbbaze and lot tcbjtr.Batches were not at the same time in the san angelo site.Between batch tbbaze and tcbjtr there were a total of 262 batches/line clearances.Lot tcbjtr belongs to code product code sxmp1b434 and was manufactured on mar/30/2023, with and expired date of feb/28/2025.Lot tbbaze was manufactured on feb/4/2023, and expired date of jan/ 31/2025.Based on objective evidence provided by san angelo and san lorenzo.There was no overlapping between these lots at any point in either of the manufacturing sites since the lots were manufactured with a difference of 40 days.Records did not demonstrate nrs related to these lots (no rework/no pds).Manufacturing equipment have automated controls to detect product mix at both sites (2d barcodes on tray, lids, and foil package).As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: STFX SPI MCRYL+ UNI 6IN 4-0 UD
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18149566
• Report Number: 2210968-2023-08913
• Device Sequence Number: 5671696
• Product Code: GAM
• UDI-Device Identifier: 10705031236530
• UDI-Public: 10705031236530
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: N12159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2023

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: 02/28/2025
• Device Catalogue Number: SXMP1B434
• Device Lot Number: TCBJTR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2023
• 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
• Patient Sex: Unknown