MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 18"(45CM) 4-0 BLK; SUTURE, NONABSORBABLE, SILK

Catalog Number	683G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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.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.The initial information stated ¿the suture was broken during use.It was commented that suture breakages occurred easily in the same lot number." please clarify: how many sutures broke during this 1 patient procedure?.
Event or Problem Description
It was reported that a patient underwent an unknown dental and oral surgery on an unknown date and suture was used.During the procedure, the suture broke.It was commented that suture breakages occurred easily in the same lot number.There were no adverse consequences to the patient.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to fda: 1/10/2019.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.Additional evaluation summary: an unopened sample of product code 683, lot # lmr805 was returned for analysis.The issue sample was not returned for evaluation.During the visual inspection of an unopened sample, no defects were found on the package.The sample was opened and the swage and attachment area were noted to be as expected.The suture was examined and no defects or breakage suture were noted.A functional test was performed on the sample using a instron and the tensile force met the requirements.Additional information was requested and the following was obtained: how many sutures broke during this 1 patient procedure? no.Information.No further information will be provided.

• Brand Name: SILK SUTURE 18"(45CM) 4-0 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: 8169149
• Report Number: 2210968-2018-77806
• Device Sequence Number: 1997419
• Product Code: GAP
• UDI-Device Identifier: 10705031008175
• UDI-Public: 10705031008175
• 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): 11/21/2018

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: 10/31/2022
• Device Catalogue Number: 683G
• Device Lot Number: LMR805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 01/10/2019
• Patient Sequence Number: 1