MAUDE Adverse Event Report: ETHICON INC. STFX SYM PDS+ UNI VIO 24IN 0 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number	SXPP1A441
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) this is a combination product, and the event has been reviewed for both the suture and the triclosan.Attempts are being 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.The following information was requested, but unavailable: could you please provide the lot number? no further information is available.Was the procedure completed successfully? how? no further information is available.Event date and procedure name? no further information is available.¿ trade name - irgacare®, ¿ active ingredient(s) ¿ triclosan, ¿ dosage form ¿ suture/solid/parenteral, ¿ strength ¿ = 2360 ug/m.
Event or Problem Description
It was reported that a patient underwent an unknown surgery on an unknown date and barbed suture was used.During the procedure, the suture detached from the needle.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 11/19/2021 the manufacturing records could not be reviewed as the batch number is unknown.Additional h-3 summary: one empty opened foil packet, a needle and suture product code sxpp1a440 were returned to ethicon inc for analysis.Upon visual analysis of the returned sample revealed that clip off defect was observed in the sample.The barrel hole was examined under 20x magnification and revealed a remnant suture.In addition, the extreme suture was noted to be severely cut.As per returned conditions of the sample no functional test was performed.The clip off defect observed during the visual assessment has been correlated to the manufacturing process.This defect is caused by excessive pressure on the suture during swaging of the needle and consequently breaking.Based on the information currently available, the clip off was identified during the investigation of the sample received.This product issue will be addressed through ethicon inc¿s quality system.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.

• Brand Name: STFX SYM PDS+ UNI VIO 24IN 0 S/A CT-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12520795
• Report Number: 2210968-2021-08801
• Device Sequence Number: 11634919
• Product Code: NEW
• UDI-Device Identifier: 10705031244962
• UDI-Public: 10705031244962
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K141776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/24/2021

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 Model Number: SXPP1A441
• Device Catalogue Number: SXPP1A440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 09/29/2021; 11/04/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 10/26/2021; 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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