MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 24IN 7-0 D/A RB-3; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8206H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2020; and a suture was used.During the procedure, the suture "burst" while pulling it together and tightening it down.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 06/30/2020.Additional information: an opened box with unopened samples of product was received for analysis.The complaint sample was not received for evaluation.During the visual inspection of unopened samples, no defects were found on the packages.The samples 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 with no defects, damaged or suture breakage noted.A functional test was performed and the tensile strength force was above the minimum requirement.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the samples received, no suture breakage was found and the tested samples met the finished goods requirements.

• Brand Name: PRLNE BLU 24IN 7-0 D/A RB-3
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10183624
• Report Number: 2210968-2020-04751
• Device Sequence Number: 886493
• Product Code: GAW
• UDI-Device Identifier: 10705031013322
• UDI-Public: 10705031013322
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2020

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: 01/31/2022
• Device Model Number: 8206H
• Device Catalogue Number: 8206H
• Device Lot Number: LBP678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 06/30/2020
• Patient Sequence Number: 1