MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 18IN 8-0 D/A BV130-5 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	EP8730H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: it was reported that "multiple strands tried (at least 5) and every time the surgeon tried to tie it, the prolene broke." however, the quantity of products involved entered was 10.Could you please confirm the quantity of devices that were affected by suture breakage during this single procedure (neck procedure) being reported.5 sutures available to return.Did the sutures broke while tying intraoperatively? or did it occurred during handling or removing from package prior procedure? broke while tying intraoperatively.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? frustration & additional or time.Was the patient treatment altered in anyway due to the prolonged surgery time? if yes, please explain, no.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.Investigation summary: the product was not returned for evaluation.Visual inspection was conducted on the pictures received.Visual analysis of the two pictures received determined that one box and an overwrap packet of product code ep8730h could be observed.The reported condition could not be observed in the picture.No conclusion could be reached as to what caused the reported complaint since the sample was not returned for analysis.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.A manufacturing record evaluation was performed for the finished device lot number qpbaxe / ep8730h19, and no non-conformance related to the reported complaint condition were identified.Events reported via: (b)(4).
Event or Problem Description
It was reported that a patient underwent a neck surgery on (b)(6) 2021 and suture was used.During the procedure, it was reported that the suture broke when tying.Multiple strands tried (at least 5).This caused additional or time.Amount of time not specified.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PRLNE BLU 18IN 8-0 D/A BV130-5 EP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11737545
• Report Number: 2210968-2021-03908
• Device Sequence Number: 3029313
• Product Code: GAW
• UDI-Device Identifier: 10705031215931
• UDI-Public: 10705031215931
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/06/2021

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: 11/30/2025
• Device Model Number: EP8730H
• Device Catalogue Number: EP8730H
• Device Lot Number: QPBAXE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1