MAUDE Adverse Event Report: ETHICON INC. SFXSYM PDS+ UNI VIO 18IN 0 SA CT-2; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	SXPP1A407
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent an unknown surgery on an unknown date and barbed suture was used.During continuous suturing, in three needles part of the anchor which is close to the swage part was broken and flown away.It was not a control release needle.There were no adverse consequences to 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 was requested, and the following was obtained: please clarify the lot number sjmuct or skmmhj or both.Does the needle retain in the patient's tissue? no the needle did not broke.If retained, were there any patient consequences? please specify.Was there any additional tissue damage as a result of searching for the needle piece? no what is the patient¿s current status? no problem what is meant by anchor? sorry for the confusion.It means a burb.Did one of the barbs break off? yes did the fixation tab break? no did the suture break? no.D4, h4 ¿ the actual device batch number associated with this event is not known.The following possible lot numbers were reported: batch sjmuct: expiration date: jul/31/2024 date of mfg.: aug/31/2022 batch skmmhj: expiration date: aug/31/2024 date of mfg.: sep/21/2022 a manufacturing record evaluation was performed for the possible finished device lots, and no related non-conformances were identified.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned related events captured via: 2210968-2024-04713 and 2210968-2024-04715.

• Brand Name: SFXSYM PDS+ UNI VIO 18IN 0 SA CT-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19247095
• Report Number: 2210968-2024-04714
• Device Sequence Number: 20442489
• Product Code: NEW
• UDI-Device Identifier: 10705031227644
• UDI-Public: 10705031227644
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K113004
• 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

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 Catalogue Number: SXPP1A407
• Device Lot Number: SJMUCT, SKMMHJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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