MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 18IN 4-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y494G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.The following information was requested, but unavailable: it was reported the sutures are bending at the needle, could you please provide more details? when was the suture snapped (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify.Could you please confirm the total number of bent sutures involved in this event? could you please confirm the total number of snapped sutures involved in this event? 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.Related events captured via 2210968-2023-03135.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date in 2023 and suture was used.The sutures are bending at the needle causing it to snap at the suture.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Date sent to the fda: 5/24/2023.H6 component code: g07002 no device problem found.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned devices.The returned sample determined that it was received, a paper lid and one winding former with a suture outside its packaging that pertains to the product code y494g.An overall review of the sample returned shows that the needle was not present.In addition, the suture has begun with the degradation process.The winding former was examined, and a mark was observed in the slot, which indicated that the needle was placed.As the needle was not returned it could not be determined if it was broken.In addition, the foil was visually inspected, and excessive wrinkles and holes in the cavity were observed due to handling.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.Additional h3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned devices.The returned sample determined that it was received, two unopened samples that pertain to the product code y494g.In order to evaluate the condition of the returned samples, the packets were opened.The swage and attachment area of the needle were noted to be as expected.The tip and body of the needles were examined under magnification and no defects or needle breakage were found.The needles were tested by resistance test to needle and met the requirements.In addition, the sutures were dispensed without problems and examined along of the strand and no issues related to breakage suture or anomalies were observed during the evaluation.A functional test was performed using an instron equipment and the tensile force was above the minimum requirements.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.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.Related reports: 2210968-2023-03135.

• Brand Name: MCRYL UD 18IN 4-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16846973
• Report Number: 2210968-2023-03134
• Device Sequence Number: 7548027
• Product Code: GAN
• UDI-Device Identifier: 10705031059337
• UDI-Public: 10705031059337
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K964072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Model Number: Y494G
• Device Catalogue Number: Y494G
• Device Lot Number: RAMJSK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2021
• 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