MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 36IN 6-0 D/A C-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	D4946
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2024
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.Additional information was requested, and the following was obtained: please provide lot number :rmmdae.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.
Event or Problem Description
It was reported that the patient underwent a femoral popliteal bypass surgery on (b)(6) 2024, and suture was used.During the procedure, surgeon tried to tie prolene suture, under no tension, and suture snapped, fore know was thrown.Surgeon then tried again to tie, and suture snapped a 2nd time.Broken suture discarded.There was no patient consequence.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 4/8/2024.H6 component code: g07002 no device problem found.Additional information: h4 - the actual device batch number associated with this event is not known.The possible batch numbers are reported as follows: batch rmmdae exp.Date: oct/31/2026 date of mfg.: nov/8/2021 batch qamjhc.A review of the batch manufacturing records was conducted for lot rmmdae, and no related non-conformances were identified.The following information was received: the complaint was for d4946 my apologies i was not aware that the box had mixed batch, as i didn¿t look at the lot numbers, just the code.However we did remove the box, which was returned to complaints a device has been received for product code d4946 , lot qamjhc, however it has not yet been evaluated.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested, the following was obtained: 1.Were any fragments generated? if so, were they removed without additional intervention? no fragments.2.How is the patient doing post-op? are they following the normal clinical path? yes h3 investigational summary: the product was returned to ethicon for evaluation.The returned sample determined that it was received, eighteen unopened samples and one empty overwrap packet pertain to the product code d4946, lot rmmdae.As per the sampling plan, a visual inspection was performed on thirteen samples, and no defects were found on the packages.The packets were opened, and the swage and attachment area were noted as expected.The sutures were dispensed without problems and examined along the strand and no issues related to breakage sutures or anomalies were observed during the evaluation.Also, the functional test was performed using instron equipment and 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.Product complaint # (b)(4).Date sent to the fda: 4/8/2024.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/1/2024 component code: g07002 no device problem found the actual device batch number associated with this event is not known.The possible batch numbers are reported as follows: batch rmmdae exp.Date: oct/31/2026 date of mfg.: nov/8/2021 batch qamjhc mfg.Date -jan/17/2020 exp.Date -dec/31/2024 a manufacturing record evaluation was performed for the finished device lot number qamjhc / d4946, and no non-conformances related to the reported complaint condition were identified.Investigational summary: the product was returned to ethicon for evaluation.The returned samples determined that it was received two unopened samples that pertain to the product code d4946, lot qamjhc.Upon initial inspection, of the samples, no external damages were observed on the packets.In order to evaluate the condition of the returned samples, the packets were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related no defects were observed during evaluation.The functional test was performed using instron equipment and the tensile force was above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.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 product was returned to ethicon for evaluation.The returned sample determined that it was received, eighteen unopened samples and one empty overwrap packet pertain to the product code d4946, lot rmmdae.As per the sampling plan, a visual inspection was performed on thirteen samples, and no defects were found on the packages.The packets were opened, and the swage and attachment area were noted as expected.The sutures were dispensed without problems and examined along the strand and no issues related to breakage sutures or anomalies were observed during the evaluation.Also, the functional test was performed using instron equipment and 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.

• Brand Name: PRLNE BLU 36IN 6-0 D/A C-1
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• 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: 18878369
• Report Number: 2210968-2024-02831
• Device Sequence Number: 18122505
• Product Code: GAW
• UDI-Device Identifier: 10705031025134
• UDI-Public: 10705031025134
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K133356
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2024

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: D4946
• Device Lot Number: RMMDAE
• 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: 02/27/2024
• Supplement Date Received by Manufacturer: 03/25/2024; 04/08/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 04/08/2024; 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown