MAUDE Adverse Event Report: ETHICON INC. SFX SPI MCRYL+UNI VIO 9IN 2-0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	SXMP1B441
Medical Device Problem Codes	Positioning Failure (1158); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 2/26/2026.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, the following was obtained: it was reported 4 products involved, please clarify how many devices demonstrated the alleged deficiency? 4 products in total did the event occur during one or multiple patient procedures? occurred in 2 procedures.What is the total number of procedures? 2 how many devices demonstrated the alleged deficiency in each case? ¿ 4 devices what is the current patients' status? ¿ no reported problems with patients.Have any of these events been previously reported to ethicon? if so, could you please provide the corresponding reference number(s)? none to my knowledge.Regarding the case where needle was lost in patient, please provide the following information: was the needle piece(s) retrieved during the same procedure? yes what measures were implemented to retrieve the broken piece? x-ray machine was used to locate the needle for one case.In the other case, the surgeon was able to visually locate and remove the needle.Was there any additional tissue damage resulting from the search for the needle piece? ¿ no.What is current condition of the patient? ¿ patient is stable does a fragment of the needle remain in the patient¿s tissue? no if so, is there any plan in place to remove the needle piece in the future? n/a if so, could you please provide the scheduled date for the removal? n/a in which tissue structure was the broken needle located? n/a what is the surgeon's opinion of the potential consequences for the patient? n/a please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep) (b)(6).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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and barbed suture was used.It was reported that during robotic hernia cases for the surgeons, when trying to insert suture spiral down 8mm intuitive trocar port the needle detached at the swage site and fell into the patient.The needle was promptly located and removed from the patient in most situations.In one instance, the needle was lost in the patient and required x-rays to locate the lost needle.There was also complaints mentioned in our discussion regarding the suture "slipping" when trying to close the peritoneum.The slipping was typically resolved through additional pulling to engage the barbs further, however the surgeons did have concern regarding long term hold.The devices were not returning.There were no patient consequences reported.Additional information was requested.

• Brand Name: SFX SPI MCRYL+UNI VIO 9IN 2-0 S/A CT-1
• 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 ; * 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24461270
• Report Number: 2210968-2026-02063
• Device Sequence Number: 9376155
• Product Code: GAM
• UDI-Device Identifier: 10705031470057
• UDI-Public: (01)10705031470057(17)270331(10)107ZMS
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K221744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: 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: SXMP1B441
• Device Lot Number: 107ZMS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2025
• 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