MAUDE Adverse Event Report: ETHICON INC. SFXSPI MCL+ BI UD 12IN2 3-0 DA PS-2 PR; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	SXMP2B408
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/5/2024.H6 component code: g07002 - pending evaluation of returned device.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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: product code sxmp2b408, lot uabars and lot tlbbkx.1.Please clarify if the additional device belong to this complaint? 1a.If yes, did a device malfunction occur during the same procedure? 2.If not, please clarify if the additional received product belongs to a different complaint? if so, can you please provide the complaint number.3.If the device was not reported before, please provide more details of device malfunction.4.If the product doesn¿t belong to any complaint, please let us know so we can discard it or advise if the product is required to be returned.5.If you have the correct complaint product in your possession, please forward the product to ethicon as soon as possible.If you have already sent the product to ethicon, please reply to ethwcqcom@its.Jnj.Com with the ups, dhl or fedex tracker number.A device has been received, however clarification is requested whether the product belongs to this complaint.A device has been received, however it has not yet been evaluated.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that a patient underwent an a total knee replacement procedure on (b)(6) 2024 and barbed suture was used.During a total knee replacement procedure that the suture broke while closing the skin.Another suture was used to continue.There were no adverse consequences for the patient.Additional information was requested.
Additional Manufacturer Narrative
(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.Additional information: h3, h6.Additional h6 component code: g07002 incomplete device returned.Following additional information was received: please clarify if the additional device belong to this complaint.No, there should have been only lot ubbjll for this complaint if the device was not reported before, please provide more details of device malfunction.No complaint on the other lots.If the product doesn¿t belong to any complaint, please let us know so we can discard it or advise if the product is required to be returned.Discard.Investigation summary: the product was returned to ethicon for evaluation.One empty opened foil packet was received for analysis.Product code sxmp2b408.The visual assessment of the returned winding former.No suture and needle were returned for analysis.As per this condition, the event described could not be confirmed.If additional information is made available, the investigation will be updated as applicable.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - no device problem found.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.H3 investigation summary: the product was returned to ethicon for evaluation.Twenty-three representative unopened samples was received for analysis.Product code sxmp2b408.Upon initial inspection of the samples, no external damages were observed on the external packets.As per the sampling plan, a visual inspection was performed on thirteen samples, the packets were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related to the customer complaint and no defects were observed during evaluation.A functional test was performed using instron equipment and tensile force was above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/14/2025.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 information was requested, the following was obtained: product code: sxmp2b408.Product lot #: tpbccp.Product doesn¿t belong to any complaint, please discard it.

• Brand Name: SFXSPI MCL+ BI UD 12IN2 3-0 DA PS-2 PR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC 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: 20853232
• Report Number: 2210968-2024-12871
• Device Sequence Number: 15478940
• Product Code: GAM
• UDI-Device Identifier: 10705031464315
• UDI-Public: (01)10705031464315(17)260131(10)UBBJLL
• Combination Product (Y/N): Y
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K192580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/14/2025

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: 01/31/2026
• Device Catalogue Number: SXMP2B408
• Device Lot Number: UBBJLL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 12/05/2024; 01/20/2025; 02/18/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 12/23/2024; 01/21/2025; 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2024
• 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