MAUDE Adverse Event Report: ETHICON INC. SFXSPI MCL+ UD 5IN2 3-0 DA PS PR; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	SXMP2B411
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a total knee replacement on (b)(6) 2024 and suture was used.It was reported that while closing the subcutaneous of five total knee replacement procedure that the suture feels like it is a "popoff" and the needle comes off the suture at the swedge.Two of the procedures did not need additional suture to complete the procedure but three of them needed to open a second device to finish.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/11/2024.H6 component code: g07002 - no device problem found.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.Additional information was requested, the following was obtained: can you identify the lot number of the product that was used? tkbdea.Please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep) joy walters - lead nurse also met with and spoke to sa¿s in the room.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.Part 1 of shipper kit has been returned.Second part shipper kit was delivered today.Will ship out tomorrow.H3 investigational summary: the product was returned to ethicon for evaluation.One needle-suture piece outside its packaging was returned for analysis.Upon visual inspection, the returned sample, the swage, and the attachment area were noted to be as expected.The needle was noted with the suture to be still attached to the barrel hole.Overall, no needle pull-off was observed.The product code sxmp2b411 contains an absorbable suture.Since the sample was received open, the functional test could not be performed due to undetermined exposure time to the environment.The extreme of the suture piece was observed to be cut possibly caused by a surgical instrument.

• Brand Name: SFXSPI MCL+ UD 5IN2 3-0 DA PS 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 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20190619
• Report Number: 2210968-2024-09494
• Device Sequence Number: 12527208
• Product Code: GAM
• UDI-Device Identifier: 10705031464407
• UDI-Public: (01)10705031464407(17)AUG/31/2025(10)TKBDEA
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K182873
• 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
• Report Date (Section B): 09/11/2024

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: 08/31/2025
• Device Catalogue Number: SXMP2B411
• Device Lot Number: TKBDEA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2023
• 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