MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 18IN 6-0 S/A P-1 PRM; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	8697G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot number mmp892, and no non-conformances related to the reported complaint condition were identified.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that the patient underwent rhinoplasty procedure on (b)(6) 2019 and suture was used.During the procedure, the needle popped off of the suture at the swage while passing through tissue.A like device was used to complete the procedure with no patient consequences reported.No part of the suture fell into the patient.
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: an empty opened box and twelve representative samples of product code 8697, lot # mmp892 were returned for evaluation.The complaint sample was not received.During the visual inspection of twelve 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 of the strand and no defects, or damaged were observed.A functional test was performed and the pull force were above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the conditions of the samples received, no performance pull off suture needle was found, and the tested samples met the finished goods requirements.Representative samples returned to support investigation of 2 device issues captured in reports 2210968-2019-83499 and 2210968-2019-83500.Analysis results have been included in follow-up reports for each.

• Brand Name: PRLNE BLU 18IN 6-0 S/A P-1 PRM
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8749512
• Report Number: 2210968-2019-83500
• Device Sequence Number: 1926091
• Product Code: GAW
• UDI-Device Identifier: 10705031019218
• UDI-Public: 10705031019218
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2019

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: 10/31/2023
• Device Catalogue Number: 8697G
• Device Lot Number: MMP892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 07/29/2019
• Patient Sequence Number: 1