MAUDE Adverse Event Report: ETHICON INC. SFX SPI MCRYL+ UNI UD 27IN 2-0 S/A PSL; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Catalog Number SXMP1B421

Device Problems Break (1069); Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2023

Event Type  malfunction  

Manufacturer Narrative

(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.Additional information was requested and the following was obtained: please clarify if the needle broke into separate pieces or if the entire needle separated from the suture.The needle snapped in to two pieces was there any additional tissue damage as a result of searching for the needle piece? no additional tissue damage was caused attempts are being 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.H6 component code: g07002 ¿ device not returned.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.

Event Description

It was reported that a patient underwent a total knee replacement procedure on (b)(6)2023 and barbed suture was used.The doctor was finishing off the skin closure with three back stitches.During the third pass the needle appeared to struggle penetrating the tissue and snapped.The distal portion of the needle was embedded in the skin but was quickly retrieved with a pair of mosquito forceps.The procedure was successfully completed with no delay.There were no adverse patient consequences.Additional information was requested.

• Brand Name: SFX SPI MCRYL+ UNI UD 27IN 2-0 S/A PSL
• Type of Device: 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: 17957018
• MDR Text Key: 325936604
• Report Number: 2210968-2023-07932
• Device Sequence Number: 1
• Product Code: GAM
• UDI-Device Identifier: 10705031236424
• UDI-Public: 10705031236424
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

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
• Device Operator: Health Professional
• Device Catalogue Number: SXMP1B421
• Device Lot Number: TDBCRB
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1