MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI 18IN 3-0 SA PS-2 PRM; SUTURE, SURGICAL, ABSORBABLE

Model Number	SXPP1A101
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional information was requested, and the following was obtained: did the suture break or did the needle detach from the thread during this patient procedure? the suture broke.What was the name of the procedure? no further information is available.Was the needle piece removed from the patient during the same procedure? no further information is available.What tissue/ location was suturing when pull off occurred? no further information is available.Were there any unexpected outcomes or complications as a result of this suture.Needle pull off event? no further information is available.Patient condition? no further information is available.Procedure name and date? no further information is available.Event date? no further information is available.Lot number? no further information is available.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 this is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - stratafix¿, active ingredient(s)- triclosan, dosage form - suture/solid/parenteral, strength - = 2360 g /m.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and barbed suture was used.During the procedure, the connection part between the suture and the needle broke during use.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 12/13/2021.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 h3 investigation summary: one empty labeled winding former, a needle and a suture piece of product code sxpp1a101 were returned for analysis.In order to evaluate the conditions of the returned sample, the swage area and hole of the needle were noted with marks that appears to be by surgical instrument.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.During the visual inspection of the suture, body fluids and marks on the surface due to use were found, the end was cut by sharp edge.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.Functional test was not performed, due to needle was received detached from suture.The manufacturing records could not be reviewed as the batch number is unknown.The condition of the sample received indicates improper handling of the device.As part of quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: SFX SYM PDS+ UNI 18IN 3-0 SA PS-2 PRM
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12760628
• Report Number: 2210968-2021-10975
• Device Sequence Number: 17207129
• Product Code: NEW
• UDI-Device Identifier: 10705031227743
• UDI-Public: 10705031227743
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K113004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2021

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 Model Number: SXPP1A101
• Device Catalogue Number: SXPP1A101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 12/13/2021
• 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