MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 30"(75CM) 6-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	8889H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2019
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.The following information was requested, but unavailable: confirm the specific number of devices (total qty actually involved with reported issue) that failed during this one event report/procedure for the reported lot?.
Event or Problem Description
It was reported that the patient underwent an unknown vascular procedure on (b)(6) 2019 and suture was used.The suture broke during use.It is unknown what was used to complete the procedure.There were no patient consequences reported.
Additional Manufacturer Narrative
A manufacturing record evaluation was performed for the finished device batch mkh809-8889h and no non-conformances were identified.A detached needle of product code 8889 received for evaluation.During the visual inspection of detached needle, the swage and attachment area were noted to be as expected and marks by use of a surgical instrument could be observed on the body needle.No remnant suture was observed into the barrel hole and the suture was not received to determine the assignable cause.Due to needle condition and that the suture was not received for evaluation, it could not be determined what may have caused the reported incident of: ¿the suture keeps breaking¿.

• Brand Name: PROLENE SUTURE 30"(75CM) 6-0 BLU
• 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: 8693223
• Report Number: 2210968-2019-82689
• Device Sequence Number: 19318163
• Product Code: GAW
• UDI-Device Identifier: 10705031021754
• UDI-Public: 10705031021754
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K133356
• 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): 05/16/2019

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: 08/31/2023
• Device Catalogue Number: 8889H
• Device Lot Number: MKH809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 07/24/2019
• Patient Sequence Number: 1