MAUDE Adverse Event Report: ETHICON INC. SFXSPI MCL+ UNI UD 18IN 4-0 SA PS-2 PMP; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Catalog Number	SXMP1B118
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint#: (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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.The following information was requested, but unavailable: additional information was requested, and the following was obtained via: did the needle fall into the patient? if so, no.Were x-rays taken to locate the needle? no.What measures were taken to retrieve the needle? needle was in needle driver when it detached from the suture.Was there any additional tissue damage as a result of searching for the needle? none noted.Provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).Dr.(b)(6), do, mba, facos, surgeon.Information gathered at time of the complaint 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.Package shipped friday november 9th.Tracking#: (b)(4).Estimated delivery: 11/12.H3 investigation summary: the product was returned to ethicon for evaluation.One detached needle outside its packaging was received for analysis.Product code: sxmp1b118.During the visual inspection of the detached needle, the hole and swage area were noted with significant tooling marks probably caused by a surgical instrument.In addition, it was noticed that the end needle was crushed.The barrel hole of the needle was examined with magnification, and no suture remnant was noted.The suture was not returned for analysis.The instructions for use contain the following caution: to avoid this kind of damage: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.
Event or Problem Description
It was reported that a patient underwent a reduction mammoplasty procedure on (b)(6) 2024 and barbed suture was used.During the procedure, it was reported by the sales rep that during a breast reduction, the needle broke off of the suture while suturing.The needle was obtained.The needle broke after passing.Case was completed with like device.No patient harm was reported.Device is available for return.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: SFXSPI MCL+ UNI UD 18IN 4-0 SA PS-2 PMP
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC 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: 20841933
• Report Number: 2210968-2024-12799
• Device Sequence Number: 8152201
• Product Code: GAM
• UDI-Device Identifier: 10705031236707
• UDI-Public: (01)10705031236707(17)250531(10)TGBDAU
• Combination Product (Y/N): Y
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/04/2024

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: 05/31/2025
• Device Catalogue Number: SXMP1B118
• Device Lot Number: TGBDAU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown