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	01/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint number: (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Investigation summary: the product was returned for evaluation.A visual inspection of the sample returned was conducted.Visual analysis of the returned product revealed that one opened sample product code sxmp1b118 was received for evaluation.Upon visual inspection of the returned sample, the suture barbs were to be damaged at the tips, in addition the secondary loop was observed missing, and the primary loop damaged, cutting appears to be by use of surgical instrument.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: please provide lot number.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 a pacemaker surgery on (b)(6) 2022 and barbed suture was used.During the procedure, the loop on the end of the suture broke during skin closure.Another like device was used to complete the procedure.There were no adverse consequences for the patient.Additional information was requested.

• 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 PR; road 183, km. 8.3; san lorenzo PR ; *
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13400755
• Report Number: 2210968-2022-00745
• Device Sequence Number: 11986318
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/31/2022

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: SXMP1B118
• Device Catalogue Number: SXMP1B118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 01/31/2022
• 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