MAUDE Adverse Event Report: ETHICON INC. SFX SPI MCRYL+ UD 12IN2 3-0 D/A PS PRM; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	SXMP2B412
Medical Device Problem Codes	Material Discolored (1170); Defective Component (2292); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
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: what was the appearance of the suture packaging? was the seal broken or were there holes that could lead to the suture drying out? - no, packaging was intact.Is this device available for analysis? - yes, defective suture and remaining unopened suture from original box returned in shipper kit.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.The manufacturing record evaluation was performed and identified a non-conformance, which was raised to address the event reported.The necessary actions have been taken to address the issue.Related events captured via 2210968-2024-02537, 2210968-2024-02538, 2210968-2024-02539, 2210968-2024-02540, 2210968-2024-02541, 2210968-2024-02542, 2210968-2024-02543.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6( 2024 and barbed suture was used.When they were getting the suture out of the packaging with the needle holder, the product appeared dry rotted but is within date and was stored per ifu.The sharps were discarded.The case was completed with a suture from another box.No patient harm was reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/27/2024.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 returned sample determined that seven opened samples without foil and four unopened samples that pertain to the product code sxmp2b412 were received for evaluation.During the visual inspection of the open samples, the sutures were noted with the degradation due to the environment exposure of the open samples; this caused the change of the appearance in the sutures to change and also were noted to be broken.The time of exposure of the suture to the environment could not be determined.The foil packets were not returned to determine the assignable cause.The samples were shipped to the ethicon raritan to perform additional analysis on the four sealed samples.Samples were analyzed to determine package integrity.During the integrity analysis, it was observed that in samples #1 and #2 with the cavity number printed on foils #5 and #4, the integrity of the sterile barrier failed the test; however, samples #3 and #4 with the cavity number printed on foils #5 and #6 passed the sterile barrier integrity test.Based on the information currently available, open seal was identified during the investigation of the samples received.This product issue will be addressed through the ethicon quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.

• Brand Name: SFX SPI MCRYL+ UD 12IN2 3-0 D/A PS PRM
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• 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: 18851146
• Report Number: 2210968-2024-02543
• Device Sequence Number: 20636701
• Product Code: GAM
• UDI-Device Identifier: 10705031464285
• UDI-Public: 10705031464285
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K182873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2024

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 Expiration Date: 06/30/2024
• Device Catalogue Number: SXMP2B412
• Device Lot Number: SHBAEC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2024
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3017102971-3/06/24-001-R
• Patient Sequence Number: 1
• Patient Sex: Unknown