MAUDE Adverse Event Report: ETHICON INC. SFX SPI MCRYL+ UNI 27IN 3-0 SA PS-2 PRM; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Model Number	SXMP1B109
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint number: (b)(4).Device not returned.This report is being submitted pursuant to the provisions of 21 cfr, part 803, 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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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 tissue was being sutured when the event occurred? ans: skin / subcuticular.Was additional dissection required in other organs/tissues other than the target tissue? ans: no.Was there any change in the patient¿s post operative care due to the prolonged procedure? ans: prolong surgery due to need to remove the broken suture.Was more than half the needle retained in the patient? ans: broken suture around 5cm near to the needle part.Where is the needle retained; in what structure? ans: nothing retain in the patient body , surgeon remove all parts.Are there plans to remove the retained needle piece? ans: remove on the spot.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.This is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name irgacare.Active ingredient(s) triclosan.Dosage form suture/solid/parenteral.Strength 2360 g /m.
Event or Problem Description
It was reported that a patient underwent a laparotomy on (b)(6) 2022 and suture was used.During use on the patient when used to close skin using subcuticular stitch.After a few passes , the needle broke into 2.Surgeon used monocryl 3/0 to continue to close skin.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 09/30/2022 this is a combination product, and the event has been reviewed for both the suture and the triclosan.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: d9, h3, h6 h6 component code: g07002 - no device problem found h3 evaluation: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that a labeled winding former and one needle-suture combination in two section of the product were received.In order to evaluate the conditions of the returned sample, the needle was examined, and no issues related to breakage needle or anomalies were found.However, it was observed that the suture pieces had begun with a degradation process caused by exposure to the environment.In addition, the foil was not returned to determine the assignable cause.According to condition of the needle the reported complaint could not be confirmed.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Trade name - irgacare® active ingredient(s) ¿ triclosan dosage form ¿ suture/solid/parenteral strength ¿ = 2360 ¿g/m.

• Brand Name: SFX SPI MCRYL+ UNI 27IN 3-0 SA PS-2 PRM
• 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
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15365878
• Report Number: 2210968-2022-07316
• Device Sequence Number: 1727790
• Product Code: GAM
• UDI-Device Identifier: 10705031236608
• UDI-Public: 10705031236608
• Combination Product (Y/N): Y
• Initial Reporter Country: MY
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2022

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 Model Number: SXMP1B109
• Device Catalogue Number: SXMP1B109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 09/06/2022
• Supplement Report FDA Received Date: 10/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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