MAUDE Adverse Event Report: ETHICON INC. GUT PL UD 18IN 6-0 D/A G-1 PRM; SUTURE, ABSORBABLE, NATURAL

Catalog Number	770G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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 ptosis procedure on (b)(6) 2018 and suture was used.During use, the needle popped off without any tension.Case completed with another device of the same product code.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/16/2018.Evaluation: a foil with a winding former and a needle/suture combination in two section were received for analysis.The product is double armed.During the visual inspection of the sample (two needle-suture pieces), the swage and attachment area of needles were as expected; the ends of the suture pieces appeared to be cut by use of the surgical instrument.Also the ends were matched among them.A functional test was performed and the pull force was above the minimum requirements.Per the conditions of the sample received, no attachment defects were found, and the tested sample met the finished goods requirements.

• Brand Name: GUT PL UD 18IN 6-0 D/A G-1 PRM
• 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: 8094204
• Report Number: 2210968-2018-77282
• Device Sequence Number: 11259482
• Product Code: GAL
• UDI-Device Identifier: 10705031010475
• UDI-Public: 10705031010475
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• 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): 10/26/2018

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 Catalogue Number: 770G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 12/16/2018
• Patient Sequence Number: 1