MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 18"(45CM) 3-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	663G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 during a basic surgical skills course/skills lab on an unknown date suture was used.The thread broke off from the needle.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).An empty opened overwrap packet, a labeled winding former with a needle and a suture of product code 663, lot mhp847 were returned for analysis.During the visual inspection of opened sample, the swage and attachment area were not as expected; since the hit of the stake was on the edge of needle, causing that the suture was severely damaged (cut) resulting in a clip off.Per the sample condition the assignable cause of the performance pull off suture needle is incorrect swage defect resulting in a clip off defect.A manufacturing record review was performed for the finished device batch mhp847 and no non-conformances were identified.

• Brand Name: ETHILON SUTURE 18"(45CM) 3-0 BLK
• 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: 8500239
• Report Number: 2210968-2019-80209
• Device Sequence Number: 16773179
• Product Code: GAR
• UDI-Device Identifier: 10705031007772
• UDI-Public: 10705031007772
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 03/14/2019

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: 06/30/2023
• Device Catalogue Number: 663G
• Device Lot Number: MHP847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 05/03/2019
• Patient Sequence Number: 1