MAUDE Adverse Event Report: ETHICON INC. STFX SPI MCRYL+ UNI 6IN 4-0 UD; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Catalog Number	SXMP1B434
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2024, and barbed suture was used.The needle got bent before using on the patient during the surgery.Changed to another one to complete the procedure.There was no patient consequence reported.Additional information was requested.
Additional 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.The following information was requested, but unavailable: if possible, please provide the lot number.--unk.H3 analysis summary: the product was returned to ethicon for evaluation.Visual inspection evaluation was conducted on the returned device.The returned sample determined that it was received, one open sample that pertain to product code (b)(4).During visual inspection of the returned sample, it was observed that the needle was noted to be broken at the swage area, this caused the needle to be bent.The other section of the needle was not returned for evaluation.This sample will be shipped to hsa for further analysis due to the needle breakage.No conclusion could be reached due to the sample needs additional evaluation by hsa.As part of the 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.The manufacturing records could not be reviewed as the batch/lot number is unknown.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/9/2024.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 summary: the product received for analysis was identified as product code sxmp1b434.Visual inspection and metallurgical analysis were performed on the returned product.A fracture was observed at the suture attachment of the needle.The needle was received in one piece as it was not completely fractured.The needle was noted with marks that appears to be by surgical instrument.A scanning electron microscope (sem) was used to examine the fracture surface and surrounding area of the needle.The fracture surfaces were examined in multiple locations to determine the fracture mode.The evaluation of the sample revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile fracture mode.This was a ductile fracture.The evidence of this examination indicates that the breakage occurred at the attachment area of the needle during use due to tensile overload.There is no evidence of any material flaw or defect that would cause premature failure.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: STFX SPI MCRYL+ UNI 6IN 4-0 UD
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18913157
• Report Number: 2210968-2024-03116
• Device Sequence Number: 15214532
• Product Code: GAM
• UDI-Device Identifier: 10705031236530
• UDI-Public: 10705031236530
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2024

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 Catalogue Number: SXMP1B434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 04/09/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown