MAUDE Adverse Event Report: ETHICON INC. SFXSPI MCL+ UNI UD 12IN 3-0 SA PS-2 PR; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	SXMP1B106
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional information: h6 component code: g07002 - device not returned.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Additional information has been requested and received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Can you identify the lot number of the product used? n/a, was discarded.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? no complications.Did the needle fall into the patient? no.If yes, was the needle piece(s) retrieved during the same procedure?; were x-rays taken to locate the needle piece(s)?; what measures were taken to retrieve the broken piece?; does a piece of the needle remain in the patient¿s tissue? no.If yes, is there any plan in place to remove the needle piece in the future? if yes, please provide the scheduled date.What tissue structure the broken needle was located? what is the surgeon's opinion of consequences to the patient? please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep) - (please refer the attached email).Please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.Product was not kept.No product is available for return.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 a patient underwent a total knee procedure on (b)(6) 2025 and suture was used.The tip had broken off during use.There was a delay in closure.Case was completed with a like device.No patient harm was reported.Additional information has been requested.

• Brand Name: SFXSPI MCL+ UNI UD 12IN 3-0 SA PS-2 PR
• 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 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21587673
• Report Number: 2210968-2025-02614
• Device Sequence Number: 8868123
• Product Code: GAM
• UDI-Device Identifier: 10705031236684
• UDI-Public: 10705031236684
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: N12159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/12/2025

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 Catalogue Number: SXMP1B106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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