MAUDE Adverse Event Report: ETHICON INC. SFXSPI PDS+ BI VIO 9IN2 3-0 DA PS PR; STRATAFIX SPIRAL PDS PLUS BIDIRECTIONAL KNOTLESS TISSUE CONTROL DEVICE

Catalog Number	SXPP2B419
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.H3 investigation summary: the product was returned to ethicon for evaluation.One strand double armed outside its packaging that pertain to product code sxpp2b419 was received for analysis.During the visual inspection of the returned sample, marks probably caused by a surgical instrument were observed on the body needles.The suture was examined, and body fluids and several particles stocked on the tips appear to be lint residue were noted.As per the condition of the sample, the barbs could not be measured.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.No conclusion could be reached as to what caused the reported complaint.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, and the following was obtained via: lot number of (b)(4): unk = tbbema.Additional event information: english.The product was used for continuous suturing.
Event or Problem Description
It was reported that a patient underwent an unknown orthopedic procedure on an unknown date and barbed suture was used.During the procedure, it was reported by a sales rep that, it could not be used because it was not hooked.Another package could use without problem.It was not a control release needle.Further details are not provided from the hp.No adverse patient consequences were reported.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.An additional device was received, and clarification was requested whether the product belongs to this complaint.The following information was requested, and the following was received: could you please clarify if the additional device belongs to this complaint? we received the tray and package at a time and the returned products belongs to this complaint.Therefore, there was a possibility that the reported product code was wrong.If yes, did a device malfunction occur during the same procedure? issue was that the barbs were too short.If not, could you please clarify if the additional received product belongs to a different complaint? if so, can you please provide the complaint number.Na.If the device was not reported before, please provide more details of device malfunction.Na.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.

• Brand Name: SFXSPI PDS+ BI VIO 9IN2 3-0 DA PS PR
• Common Device Name: STRATAFIX SPIRAL PDS PLUS BIDIRECTIONAL KNOTLESS TISSUE CONTROL DEVICE
• 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: 20146531
• Report Number: 2210968-2024-09292
• Device Sequence Number: 8397422
• Product Code: NEW
• UDI-Device Identifier: 10705031464780
• UDI-Public: (01)10705031464780(17)250131(10)TBBEMA
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K192144
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024

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: 01/31/2025
• Device Catalogue Number: SXPP2B419
• Device Lot Number: TBBEMA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2023
• 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