MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 30"(75CM) 3-0 BLK; SUTURE, NONABSORBABLE, SILK

Catalog Number	C017D
Medical Device Problem Code	Incorrect Device Or Component Shipped (2962)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.How many sutures had a 1-0 diameter instead of a 3-0 diameter, one or three? if the quantity is three please provide the product code and lot number for those devices.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2017 and suture was used.During use on a patient, it was found that the size was 1-0, not 3-0.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Additional information was requested and the following was obtained: 1.How many sutures had a 1-0 diameter instead of a 3-0 diameter, one or three? one identified.3 threads were used before complaint identified.However, it could not be confirmed if the used 3 threads were 1-0 diameter of 3-0 diameter.2.If the quantity is three please provide the product code and lot number for those devices.The product code and lot number were already provided.As the complaint was captured during the follow up for ha request, the specific customer cannot be identified.

• Brand Name: SILK SUTURE 30"(75CM) 3-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7462797
• Report Number: 2210968-2018-72357
• Device Sequence Number: 1030195
• Product Code: GAP
• UDI-Device Identifier: 10705031023499
• UDI-Public: 10705031023499
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 04/04/2018

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: 07/31/2022
• Device Catalogue Number: C017D
• Device Lot Number: LJR998
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 04/25/2018
• Supplement Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1