MAUDE Adverse Event Report: ETHICON INC. SFX SPI MCRYL+ UNI 18IN 4-0 SA PS-2 PRM; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Model Number	SXMP1B118
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.This is a combination product, and the event has been reviewed for both the suture and the triclosan.Additional information was requested, and the following was obtained: please provide the lot number for the stratafix spiral monocryl plus (product code: sxmp1b118).Lot #rhbbla.Please provide the lot number for the silk suture (product code k834h).Lot #rcbbka.When did the sutures broke (in the package, during removal from package, during handling or during use on the patient)? please specify for both of the two sutures.During use on the patient for both sutures attempts have been made to retrieve the device.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.Trade name - stratafix¿, active ingredient(s)- triclosan, dosage form - suture/solid/parenteral, strength - = 2360 ug /m.Events reported via: 2210968-2021-10738.
Event or Problem Description
It was reported that a patient underwent a coronary procedure on (b)(6) 2021 and barbed suture was used.During the procedure, the suture broke.Another like device was used to complete the surgery.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #(b)(4).Date sent to the fda: 11/24/2021.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.H3: investigational narrative: visual analysis of the returned product revealed that one opened sample product code sxmp1b118 was received to ethicon inc for evaluation.Upon visual inspection of the returned sample, the suture was to be damaged at the surface, body fluids and the barbs were to be damaged at the tips.In addition, the end was observed cut.After further evaluation crimping marks were observed on the surface suture possibly from a surgical instrument.The product code sxmp1b118 contains absorbable suture, as the sample was received open, the time of exposure to the environment could not be determined and a functional test cannot be performed.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.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.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Trade name - stratafix¿ active ingredient(s)- triclosan dosage form - suture/solid/parenteral strength: 2360 g /m.

• Brand Name: SFX SPI MCRYL+ UNI 18IN 4-0 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; road 183, km. 8.3; san lorenzo PR
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12738372
• Report Number: 2210968-2021-10501
• Device Sequence Number: 4099481
• Product Code: GAM
• UDI-Device Identifier: 10705031236707
• UDI-Public: 10705031236707
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2021

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: 06/30/2023
• Device Model Number: SXMP1B118
• Device Catalogue Number: SXMP1B118
• Device Lot Number: RHBBLA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2021
• 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