MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 36"(90CM) 4-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8357H
Medical Device Problem Codes	Break (1069); Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot number mkh336, and no non-conformance's related to the reported complaint condition were identified.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 the patient underwent an unknown procedure on an unknown date and suture was used.During use, the suture was found split and broke.Changed to another device to complete the procedure.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).A labeled winding former with two re-parked needle/suture pieces of product code 8357, lot # mkh336 was received for evaluation.During the visual inspection of two detached needle, the swage and attachment area were noted to be as expected and marks by use of a surgical instrument could be observed.In addition, a suture piece was noted attach to needle and present damaged by surgical instrument.The other section of the suture was not received for evaluation and no functional test could be performed.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, the assignable cause of the fraying suture is an improper handling.Additional information was requested and the following was obtained: could not identify which one, please analyze both 2 devices.

• Brand Name: PROLENE SUTURE 36"(90CM) 4-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9238266
• Report Number: 2210968-2019-89045
• Device Sequence Number: 13491503
• Product Code: GAW
• UDI-Device Identifier: 10705031014725
• UDI-Public: 10705031014725
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/27/2019

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: 8357H
• Device Lot Number: MKH336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 11/22/2019
• Patient Sequence Number: 1