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	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 a total knee replacement procedure on an unknown date and barbed suture was used.It was reported that the suture broke halfway up on the needle on the second pass.They continued to use it for that same side and got another one to complete the total knee procedure without patient harm.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/13/2024 h6 component code: g07002 - device not returned.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: please address the questions below for each patient event: ¿ what is the procedure date? ¿ which part of the device broke during the procedure, the suture or the needle? please clarify ¿ if the needle broke, please clarify, was the broken needle piece retained in patient? if yes, how was it retrieved? ¿ did this issue cause any procedural delay? ¿ did this issue contribute to any patient adverse event? ¿ is the device available to be returned for evaluation? if so, please provide the status of the return and any available tracking information.¿ please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep) 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.

• 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: 19974300
• Report Number: 2210968-2024-08421
• Device Sequence Number: 6964041
• Product Code: GAM
• UDI-Device Identifier: 10705031464407
• UDI-Public: (01)10705031464407(11)230915(17)250831(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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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