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

Catalog Number 1916G

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2018

Event Type  malfunction  

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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.

Event Description

It was reported that patient underwent an arthroplasty procedure on (b)(6) 2018 and suture was used.The needle popped off the suture at the swage.Another like device was used to complete the procedure.There were no patient consequences reported.

Manufacturer Narrative

Representative samples were returned for analysis.The issue sample was not received for evaluation.During the visual inspection of five representative samples, no defects were found on the packages.The samples were opened and the swage and attachment area were as expected.The sutures were examined along of strand and no defects or needle pull were noted.Functional test was performed on the samples and the pull force test met the requirements.

• Brand Name: GUT PL FAG UD 18IN 6-0 S/A PC-1 PRM MP
• Type of Device: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez ; MX
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7451209
• MDR Text Key: 106250589
• Report Number: 2210968-2018-72283
• Device Sequence Number: 1
• Product Code: GAL
• UDI-Device Identifier: 10705031002920
• UDI-Public: 10705031002920
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/02/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 1916G
• Device Lot Number: LLK236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2018
• Initial Date FDA Received: 04/23/2018
• Supplement Dates Manufacturer Received: 04/19/2018
• Supplement Dates FDA Received: 05/15/2018
• Date Device Manufactured: 10/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1