MAUDE Adverse Event Report: ETHICON INC. SFX SPI MCRYL+ UNI 27IN 3-0 SA PS-2 PRM; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Model Number SXMP1B109

Device Problem Dull, Blunt (2407)

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

Event Date 11/21/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Component code: c22 - photo analysis.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, the following was obtained: was there any change in the patient¿s post-operative care due to the prolonged procedure? unknown.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? unknown.What is the lot number? shbhha.Investigational summary: the product received for analysis was identified as product code sxmp1b109.Visual inspection and metallurgical analysis were performed on the returned product.A fracture was observed at the tip of the needle.One side of the needle was received, the mating fracture surface was not provided for this evaluation.Visual inspection and metallurgical analysis were performed on the returned product.A scanning electron microscope was used to examine the fracture surfaces 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.Mechanical damage observed coincidental to the fracture provides additional evidence that the failure was induced by mechanical deformation leading to ductile overload.This was a ductile fracture.The evidence of this examination indicates that the breakage occurred at the tip 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.Photo analysis: this is an analysis of a photo submitted to ethicon for evaluation.During the visual analysis the following was observed: the photo shows an apparently damaged needle.A clear analysis could not be performed as the photo becomes distorted when magnified.Based on the photo review, the event describe is not confirmed, however no conclusion or root cause could be determined.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.Trade name - stratafix¿, active ingredient(s)- triclosan, dosage form - suture/solid/parenteral, and strength - = 2360 g /m.

Event Description

It was reported from the analysis of the returned product that a needle breakage occurred, a fracture was observed at the tip of the needle.It was reported by the customer that during gyn procedure on (b)(6) 2022, during subcuticular closure the needle was noted to be blunt by surgeon.Surgical tech inspected needle and compared to a new needle.Was immediately sequestered and packaging set aside.The surgery was delayed by two minutes.The procedure was completed successfully.There were no patient consequences reported.Additional information was requested.

• Brand Name: SFX SPI MCRYL+ UNI 27IN 3-0 SA PS-2 PRM
• 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 ; *
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16218531
• MDR Text Key: 307939569
• Report Number: 2210968-2023-00443
• Device Sequence Number: 1
• Product Code: GAM
• UDI-Device Identifier: 10705031236608
• UDI-Public: 10705031236608
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/20/2023

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 Model Number: SXMP1B109
• Device Catalogue Number: SXMP1B109
• Device Lot Number: SHBHHA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2023
• Initial Date Manufacturer Received: 01/13/2023
• Initial Date FDA Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2022
• 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
• Patient Sex: Female