MAUDE Adverse Event Report: ETHICON INC. GUT PL UD 18IN 4-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, NATURAL

Catalog Number	1644G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/25/2018
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 a patient underwent a dental procedure on (b)(6) 2018 and suture was used.During the procedure, the suture was splitting.There were no adverse patient consequences.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).An opened box with unopened representative samples were returned for analysis.During the visual inspection of the samples, no defects were found on the packages.The samples were opened, and the swage and attachment area of needles were as expected.The sutures were dispensed without problems and examined along of the strand and no defects, damaged or suture breakage were observed.A functional test was performed and the tensile force were above the minimum requirements.Per the condition of the representative samples, no breakages were found on the sutures and the tested samples met the finished goods requirements.

• Brand Name: GUT PL UD 18IN 4-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7659132
• Report Number: 2210968-2018-74038
• Device Sequence Number: 163442
• Product Code: GAL
• UDI-Device Identifier: 10705031001572
• UDI-Public: 10705031001572
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2018

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: 12/31/2022
• Device Catalogue Number: 1644G
• Device Lot Number: MAZ030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Initial Date Received by Manufacturer: 06/08/2018
• Supplement Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 08/27/2018
• Patient Sequence Number: 1