MAUDE Adverse Event Report: ETHICON INC. SFXSPI MCL+ UNI UD 6IN 4-0 SA RB-1; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	SXMP1B434
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - device not returned.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.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The following information was requested, but unavailable: was there any adverse consequence associated with the patient? - were there any unexpected outcomes or complications as a result of the prolonged surgery time? - how long (in minutes) did the surgery prolong? - what tissue was being sutured when the event occurred? - was additional dissection required in other organs/tissues other than the target tissue? - was there any change in the patient¿s post operative care due to the prolonged procedure? please refer to the event description, other information requested is unknown.
Event or Problem Description
It was reported that a patient underwent a laparoscopic bilateral hernia repair surgery on (b)(6) 2024 and barbed suture was used.During the procedure, on the afternoon, at 14:00, following the doctor's advice, the surgery was performed.During the laparoscopic bilateral hernia repair surgery operation, the chief surgeon used a 10mm puncture device to insert the suture into the laparoscope and found that the problem of pulling off suture needle happened.The needle was not seen, and the team leader immediately reported it to the team leader.The team leader contacted the c-arm machine for fluoroscopy and the radiology department for imaging, but no needle was found in the patient's body.Finally, the needle was found on the second layer of cloth on the operating table, and the surgery continued.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: SFXSPI MCL+ UNI UD 6IN 4-0 SA RB-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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21173217
• Report Number: 2210968-2025-00657
• Device Sequence Number: 9429743
• Product Code: GAM
• UDI-Device Identifier: 10705031236530
• UDI-Public: (01)10705031236530(17)241231(10)TABDPE
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K151200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2025

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: 12/31/2024
• Device Catalogue Number: SXMP1B434
• Device Lot Number: TABDPE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2023
• 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
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male