MAUDE Adverse Event Report: ETHICON INC. SFXSPI MCL+ UNI UD 18IN 2-0 SA CT-1; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Catalog Number	SXMP1B413
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown orthopedic surgery on an unknown date and a barbed suture was used.During the procedure, while closing, the pa was suturing normally and the string broke in two.Another like device was used to complete the procedure.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.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.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.Lot number tkbahq and tmbbka were reported, but a third, unknown lot number appears to be involved.If so, can you identify it? please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.
Additional Manufacturer Narrative
Product complaint #(b)(4).Date sent to the fda: 7/30/2024.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.H6 component code: g07002 no device problem found.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.The following information was requested: it was reported that ¿the complaint was previously submitted, but because the customer was delayed in providing an address to return the product, the complaint closed.Therefore, a new complaint was opened once a proper address was provided to send a product return kit.¿ please confirm, was an additional complaint created to capture a return product in additional to the following 3 complaints (b)(4)? if yes, please provide the product complaint number associated with the returned product.Which original product complaint number did the returned product belong to? for each patient event (b)(4) please clarify the following: how many devices were involved for each event.(currently there are 3 ip reported under each of the three files).The following information was received: the late rationale was because the complaint was previously submitted, but because the customer was delayed in providing an address to return the product, the complaint closed.Therefore, a new complaint was opened once a proper address was provided to send a product return kit.There is no third lot number, the incidences were just filed separately.All incidences that occurred were within the two lot numbers.H3 investigational summary: the product was returned to ethicon for evaluation.The returned product determined that it was received; three unopened samples that pertain to the product code sxmp1b413.In order to evaluate the condition of the returned samples, the packets were opened.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand and no issues related to breakage sutures or anomalies were observed during the evaluation.The functional test was performed using instron equipment and the tensile force was above the minimum requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: SFXSPI MCL+ UNI UD 18IN 2-0 SA CT-1
• 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: 19601090
• Report Number: 2210968-2024-06524
• Device Sequence Number: 20884138
• Product Code: GAM
• UDI-Device Identifier: 10705031236417
• UDI-Public: 10705031236417
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

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: 10/31/2025
• Device Catalogue Number: SXMP1B413
• Device Lot Number: TMBBKA
• 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: 05/28/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2023
• 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