MAUDE Adverse Event Report: ETHICON INC. MERSILENE SUTURE 18" (45CM) 6-0 WHT; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	1722G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	12/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This medwatch report is in response to receipt of voluntary medwatch report (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.Additional information was requested and the following was obtained: was the entire needle portion removed from the patient on (b)(6) 2018? i was told that no foreign body was left after (b)(6) surgery.Do you have the status of the needle piece for return? the needle device was returned in your shipping container and label on 01/27/2019.What is the current condition of the patient? patient is no longer in hospital and no complications were reported.(b)(4).
Event or Problem Description
This medwatch report is in response to receipt of voluntary medwatch report (b)(4): it was reported that the patient underwent surgery (b)(6) 2018 for right upper lid ptosis repair and suture was used.The suture was used to make a partial thickness pass through the tarsal plate.The suture was then brought out through the levator aponeurosis superiorly approximately 15 mm superior to its original position.The suture was tied temporarily in place.The lid height and contour were inspected and the suture was adjusted as needed to preliminarily achieve the desired lid height and contour.As the medial end of the suture was being passed, it was noted that the needle was not attached to the corresponding end of the suture.The operative site was explored and the needle was not located.A detailed search of the drapes and the floor and area surrounding the operating room table did not locate the needle.Radiology was consulted and the x-ray revealed "a needle foreign body is present in the postoperative right eyelid.This measures approximately 6.5 mm in length, is located 6 mm deep to the anterior skin of the right eyelid and extends to near the posterior aspect of the eyelid at approximately the 12 o'clock position of the orbit and globe." ct of facial bones (b)(6) 2018 revealed needle foreign body was present.The radiologist opined that undraping the patient and removing all potentially metallic objects would help further determine if the needle was still in the operative site, as it was not clear if what was felt to potentially be the needle really was within the operative site when viewed on the x-rays.X-ray skull (b)(6) 2018 revealed needle foreign body in the superolateral right orbit parallel to its superior border and approximately 2 mm inferior to its superior border.The needle remained in the eyelid and the patient returned to surgery on (b)(6) 2018 to remove the foreign body with no further complications reported.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device mkm067 batch number, and no non-conformances were identified.Device evaluation summary: a needle of product code 1722g, lot mkm067 was returned for analysis.During the visual inspection of the needle, the swage and attachment area were as expected.However, filaments of suture were found in the barrel hole and slightly marks on the edge of the needle that appears to be by the use of a surgical instruments were noted.Marks were observed on the edge of the needle.In order to avoid this kind of damage the packages insert (ifu) cautions: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition the assignable of the performance - pull off suture needle, suggest an improper handling of the sample.

• Brand Name: MERSILENE SUTURE 18" (45CM) 6-0 WHT
• 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: 8317927
• Report Number: 2210968-2019-78746
• Device Sequence Number: 18846832
• Product Code: GAT
• UDI-Device Identifier: 10705031002265
• UDI-Public: 10705031002265
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 1722G
• Device Lot Number: MKM067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 02/07/2019
• Supplement Report FDA Received Date: 02/21/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 88