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	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 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 lot, and no non-conformances were identified.

• 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: 8597072
• Report Number: 2210968-2019-81241
• Device Sequence Number: 11172511
• 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
• 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?: Yes
• 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
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 05/20/2019
• Patient Sequence Number: 1