MAUDE Adverse Event Report: ETHICON INC. SFXSYM PDS+ UNI VIO 18IN 3-0 SA PS-2 PMP; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	SXPP1A101
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
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.H6 component code: g07002 - pending device evaluation.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.The following information was requested but unavailable: can you identify the lot number of the product that was used?.
Event or Problem Description
It was reported that a patient underwent an unknown orthopedic surgery on (b)(6) 2024 and a barbed suture was used.During the procedure, the suture came off from the needle with use.It was a control release needle.There were no adverse consequences to the patient.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/22/2024.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.H6 component code: g07002 no device problem found.H3 investigational summary: the product was returned to ethicon for evaluation.One detached needle and one suture piece outside its packaging.Product code sxpp1a101.According to the information received, it was reported by a sales rep that, during an unknown surgery, the suture was detached from the needle even though the surgeon didn't put any force on the product.The product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Upon visual inspection of the detached needle, the attachment condition was as expected.The barrel hole of the needle was examined with magnification, and no suture remnant was noted.The suture piece was inspected, and the insertion mark was observed to be as expected.In addition, the end of the suture was noted to be cut probably caused by a surgical instrument.As per the conditions of the returned sample, no functional test could be performed.

• Brand Name: SFXSYM PDS+ UNI VIO 18IN 3-0 SA PS-2 PMP
• 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: 19822013
• Report Number: 2210968-2024-07611
• Device Sequence Number: 15676299
• Product Code: NEW
• UDI-Device Identifier: 10705031227743
• UDI-Public: 10705031227743
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

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 Catalogue Number: SXPP1A101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 08/22/2024
• 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