MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ UNI 12IN 3-0 SA PS-2 PRM; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B104
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Component code: g07002 device not returned.Attempts have been 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.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.It was reported that "there was no loop attached to the stump of suture.Was the loop missing from the beginning (in the packaging) or did it break/detach (during removal from the package, during handling before use on the patient or during use on the patient)? please specify.Please provide the lot number.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.
Event or Problem Description
It was reported that a patient underwent an orthopedic procedure on (b)(6) 2023 and barbed suture was used.There was no loop attached to stump of suture.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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: "it was reported that ""there was no loop attached to the stump of suture"" was the loop missing from the beginning (in the packaging) or did it break/detach (during removal from the package, during handling before use on the patient or during use on the patient)? please specify: the loop was missing from the beginning.Please provide the lot number: unk.Please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep): (b)(6).Please perform and document the follow-up attempt for product return.Please document the shipment tracking number in the notes or rmao sections: we regularly contact with sales rep about the device returning.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/7/2024.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.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.The returned sample revealed that it was received, one open sample that pertained to product code sxpp1b104.During visual inspection of the sample, it was observed that the first and second loop were not present.The suture was examined, and the of the suture was noted to be cut, probably caused by a surgical instrument.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached as on what caused the reported complaint.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: SFX SPI PDS+ UNI 12IN 3-0 SA PS-2 PRM
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• 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: 18504825
• Report Number: 2210968-2024-00406
• Device Sequence Number: 7948793
• Product Code: NEW
• UDI-Device Identifier: 10705031236240
• UDI-Public: 10705031236240
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: NA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2024

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: SXPP1B104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2023
• Supplement Date Received by Manufacturer: 01/29/2024; 02/19/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 02/16/2024; 03/07/2024
• 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