MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 2X24IN 7-0 D/A BV175-6 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	EPM8737
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional information was requested, and the following was obtained: it was reported by a sales rep that, some sutures in the same lot number were broken before use.Was the suture separated (pull off) from the needle in the package? according to the sales rep, the reported issue was not ""pull-off"" but suture breakage.Please clarify if sutures were broken found in the package? according to the sales rep, the suture broke before use.However, the exact timing when it broke is unknown.What is the event and procedure date? no further information is available.Do you have any photo? =>no photos are available.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received sent.Ater date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date; and a suture was used.During the procedure, the suture broke before use.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 08/05/2020.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 1/13/2021.Additional information: d9, h6.H6 component code: g07002 ¿ conforming device.A manufacturing record evaluation was performed for the finished device batch pkj333, and no non-conformances were identified.Additional h3 investigation summary: it was received for evaluation an unopened sample of product code epm8737, lot pkj333.During the visual inspection of unopened sample, no defects were found on the package.The sample was opened, and the swage and attachment area were noted to be as expected.The suture was dispensed without problems and examined along of the strand and no defects, damaged or suture breakage were noted.A functional test was performed and the tensile strength force was above the minimum requirement.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.It should be noted that as part of our quality process, device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The device performed without any defect noted and the actual complaint sample was not returned for analysis.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 2X24IN 7-0 D/A BV175-6 EP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10179209
• Report Number: 2210968-2020-04681
• Device Sequence Number: 2309635
• Product Code: GAW
• UDI-Device Identifier: 10705031207479
• UDI-Public: 10705031207479
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2020

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: 08/31/2024
• Device Model Number: EPM8737
• Device Catalogue Number: EPM8737
• Device Lot Number: PKJ333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 07/30/2020; 01/05/2021
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 08/05/2020; 01/13/2021
• Patient Sequence Number: 1