MAUDE Adverse Event Report: ETHICON INC. 6-0 PROLENE BLUE 75CM WITH PS-3 PRIME MP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	F2832
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 a dental procedure on unknown date in (b)(6) 2019 and suture was used.The suture broke during the passage in tissue before making the second knot.Another device from competitor was used to complete the procedure.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch jjj542, xvf2832 and no non-conformances were identified.
Additional Manufacturer Narrative
Product complaint #: (b)(4).

• Brand Name: 6-0 PROLENE BLUE 75CM WITH PS-3 PRIME MP
• 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: 8596980
• Report Number: 2210968-2019-81238
• Device Sequence Number: 14023553
• Product Code: GAW
• UDI-Device Identifier: 10705031238046
• UDI-Public: 10705031238046
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: F2832
• Device Lot Number: JJJ542
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/08/2019
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 05/13/2019; 05/20/2019
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 05/17/2019; 05/30/2019
• Patient Sequence Number: 1