MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 18"(45CM) 5-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	8717H
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).Investigation summary = > it was reported performance breakage suture.A suture piece of product code 8717 was returned for analysis.During the visual inspection of the suture piece, the ends were noted cut appears to be by use of a surgical instrument and marks on surface suture were noted.The other section of the suture was not returned for analysis.No functional test could be performed due to condition of the sample received.In handling this or any other suture material, care should be taken to avoid damage from handling.Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.The manufacturing records couldn't be reviewed as the batch number is unknown.According to the sample condition, the assignable cause of the performance breakage suture, was suggest an improper handling.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the suture broke while tying the knot.It is unknown if a similar device was used to complete the procedure.There were no adverse patient consequences.No additional information was provided.

• Brand Name: PROLENE SUTURE 18"(45CM) 5-0 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: 8771176
• Report Number: 2210968-2019-83786
• Device Sequence Number: 13825202
• Product Code: GAW
• UDI-Device Identifier: 10705031019638
• UDI-Public: 10705031019638
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2019

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 Catalogue Number: 8717H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 07/09/2019
• Patient Sequence Number: 1