MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 24IN 7-0 D/A BV175-8 MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	W8702
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown surgery on (b)(6) 2024 and suture was used.During the procedure, sutures snapping.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #(b)(4).H6 component code: g07002 - device not returned.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.Attempts have been 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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please provide lot number.When the event occurred.Were there any patient consequences? please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.Please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq).The manufacturing records could not be reviewed as the batch/lot number is unknown.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 12/12/2024.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, 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.H6 component code: g07002 no device problem found additional information: d4, d9, h3, h4, h6.Additional information: d4 - the actual product code associated with this event is not known.The possible product codes are reported as follows product code teball, product code tgbhud, product code tabecs.A manufacturing record evaluation was performed for the finished device batch teball, w8702 and no non-conformances were identified.Expiration date: apr/30/2028 date of mfg.: may/2/2023 udi: (b)(4).A manufacturing record evaluation was performed for the finished device batch tgbhud, w8702 and no non-conformances were identified.Mfg.Date - 06/23/2023 exp.Date - 05/31/2028 udi: (b)(4).A manufacturing record evaluation was performed for the finished device batch tabecs, w8702 and no non-conformances were identified.Expiration date: dec/31/2027 date of mfg.: dec/6/2023 udi: (b)(4).H3 investigational summary: the product was returned to ethicon for evaluation.One open box with eleven representative unopened samples were received for analysis.Product code w8702, lot tabecs.The complaint sample was not received for evaluation.Upon initial inspection of the samples, no external damages were observed on the external 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 to the customer complaint and 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.The event described could not be confirmed as no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.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.One representative unopened sample was received for analysis.Product code w8702, lot tgbhud.The complaint sample was not received for evaluation.Upon initial inspection of the sample, no external damages were observed on the external packet.In order to evaluate the condition of the returned sample, the packet was opened.The swage and attachment area were noted to be as expected.The suture was dispensed without problems and examined along the strand to detect any issue related to the customer complaint and 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.The event described could not be confirmed as no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Additional h3 investigational: the product was returned to ethicon for evaluation.One representative unopened sample was received for analysis.Product code w8702, lot teball.The complaint sample was not received for evaluation.Upon initial inspection of the sample, no external damages were observed on the external packet.In order to evaluate the condition of the returned sample, the packet was opened.The swage and attachment area were noted to be as expected.The suture was dispensed without problems and examined along the strand to detect any issue related to the customer complaint and 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.The event described could not be confirmed as no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: PRLNE BLU 24IN 7-0 D/A BV175-8 MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• 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
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20683351
• Report Number: 2210968-2024-12006
• Device Sequence Number: 12578376
• Product Code: GAW
• UDI-Device Identifier: 10705031201903
• UDI-Public: 10705031201903
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 12/12/2024

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: W8702
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 12/12/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown