MAUDE Adverse Event Report: ETHICON INC. ETHIBOND EXCEL SUTURE 30"(75CM) 5 GRN; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	D6296
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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 a patient underwent an unknown orthopedic surgery on (b)(6) 2018 where suture was used.It was found that the needle-suture had been caught at the sealed area of the package when taking out the package from the box.Another package was used for the patient.Further details are not provided.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to the fda: (b)(4) 2018.A partially opened overwrap with a folder, and three pictures of the sample were returned for analysis.During the visual inspection of the overwrap and the image inspection of the photos, a portion of the inner folder packet was caught in the sealing area.Therefore, a section of the seal was partially open compromising the sterile barrier.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the sample received and the photos observed, the assignable cause of the packaging integrity is a primary packet in the seal resulting in an opened seal.

• Brand Name: ETHIBOND EXCEL SUTURE 30"(75CM) 5 GRN
• 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: 7859648
• Report Number: 2210968-2018-75739
• Device Sequence Number: 16639348
• Product Code: GAT
• UDI-Device Identifier: 10705031026261
• UDI-Public: 10705031026261
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/13/2018

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: 06/30/2022
• Device Catalogue Number: D6296
• Device Lot Number: LHZ903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 10/09/2018
• Patient Sequence Number: 1