MAUDE Adverse Event Report: ETHICON INC. SFX SPI PGAPCL BI UD 14CM2 4-0 DA FS-2; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number	SXMD2B407
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 the same suture broken twice during sewing, was the product still used even if it was broken? the problem of pulling off suture needle had happened as soon as it was opened and taken out.It was not used in human body, and there were no adverse results for patients.Or was more than one suture broken in this event? two suture.Was there any adverse consequence associated with the patient? no.Please provide the product code and lot number: product code:sxmd2b407, lot number : b809buj.Additional information was requested: please confirm if both sutures experienced suture breakage during removal of the package and were not used on the patient.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 related to: this mfr.Report.
Event or Problem Description
It was reported that a patient underwent a wound closure procedure on (b)(6) 2022 and suture was used.During the procedure, it was reported that the same suture broke twice during sewing chin wound in surgery.Another like device was used to complete the procedure.There were no patient consequences reported.Additional information was requested.

• Brand Name: SFX SPI PGAPCL BI UD 14CM2 4-0 DA FS-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): SURGICAL SPECIALTIES MEXICO; corredor tijuana-rosarito 2000; no 24702-b ejido francisco; tijuana ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15070112
• Report Number: 2210968-2022-05707
• Device Sequence Number: 17310258
• Product Code: NEW
• UDI-Device Identifier: 10705031208087
• UDI-Public: 10705031208087
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2022

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: 07/31/2026
• Device Model Number: SXMD2B407
• Device Catalogue Number: SXMD2B407
• Device Lot Number: B809BUJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2022
• Supplement Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2021
• 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 Age: 72 YR
• Patient Sex: Unknown