MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 18IN 2-0 S/A PS-2 PRM; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	593H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2018 and suture was used.During the procedure, the suture was breaking.A different type device was used to complete the procedure with no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to the fda: (b)(4) 2018.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.A labeled winding former and a re-parked needle were returned for analysis.During the visual inspection of the sample, the swage and attachment area were as expected, but marks were observed along strands and the end was damaged (cut) from what appears to be by use of a surgical instrument.Per the conditions of the sample received, the assignable cause of the suture breakage was an improper handling.Additional information was requested and the following was obtained: 1- was there an issue of breakage with code (b)(4) lot lah125? - no suture was returned for code (b)(4) for evaluation.2-was there an issue with the product (b)(4) lot kmp968 suture experienced breakage? - yes,sorry.From what i understand, the actual suture was breaking.Not the thread.3- please confirm which of the products should be considered for this complaint case.- i¿m assuming (b)(4) lot kmp968.

• Brand Name: ETHLN BLK 18IN 2-0 S/A PS-2 PRM
• 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: 7902623
• Report Number: 2210968-2018-75944
• Device Sequence Number: 148646
• Product Code: GAR
• UDI-Device Identifier: 10705031006539
• UDI-Public: 10705031006539
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2018

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: 10/31/2021
• Device Catalogue Number: 593H
• Device Lot Number: KMP968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 10/12/2018
• Patient Sequence Number: 1